Daily Digest

The Valve Wire

Friday, May 15, 2026

Executive Summary

Today's evidence reinforces a central tension in structural heart disease: transcatheter aortic valve replacement shows clear short-term advantages over surgery in low-risk patients, but long-term certainty remains elusive — and bicuspid aortic valve disease continues to challenge TAVR's expanding indications. Two new meta-analyses in The American Journal of Cardiology confirm that TAVR's early mortality and morbidity benefits in low-risk patients fade to statistical noise by five years. Meanwhile, a multicenter observational study in the Journal of the American Heart Association finds that TAVR in bicuspid aortic stenosis carries significantly higher stroke and valve dysfunction rates at two years compared to surgery. For patients and families: the choice between catheter-based and surgical valve replacement remains highly individualized, and newer is not always better — especially for younger patients and those with bicuspid valves.

For the clinical audience: this is a data-rich day that rewards careful reading. The Swedish SWEDEHEART registry delivers granular national data on post-TAVI stroke trends (declining, but still deadly). A large Italian multicenter registry raises a red flag about balloon-expandable valves in low-flow, low-gradient AS — higher heart failure hospitalizations versus self-expanding valves. On the mitral front, the 2,601-patient REPAIR registry reveals sex-based differences in PASCAL M-TEER outcomes that matter for procedural planning. In the tricuspid space, Abbott launches TriClip in India while CPET data provide the first objective functional capacity evidence for transcatheter tricuspid interventions. And a provocative STS database analysis of nearly 18,000 patients reopens the debate about whether moderate AS should still be addressed surgically at the time of CABG — or whether the TAVR safety net changes the calculus. Let's unpack it.

Today's Key Findings

[NOTABLE] Two updated meta-analyses of low-risk TAVR vs. SAVR RCTs reach the same conclusion: TAVR's early advantages (30-day mortality RR 0.45, lower bleeding, less AF) do not translate into durable long-term superiority. At ≥5 years, all-cause death (RR 0.99, 95% CI 0.72–1.35), stroke, endocarditis, and aortic reintervention are statistically indistinguishable between groups. Pacemaker implantation remains significantly higher with TAVR. These findings directly support the current guideline framework: shared Heart Team decision-making in the 65–80 age range (ACC/AHA) and SAVR preference under age 70 (ESC 2025). The data do not support reflexive TAVR-first strategies in younger, lower-risk cohorts. (Jarade et al., Am J Cardiol; Di Pietro et al., Am J Cardiol)

[NOTABLE] TAVR vs. SAVR in bicuspid AS — SAVR signals emerge at 2 years: In 997 patients (256 propensity-matched pairs, median age 75, median EuroSCORE II 1.83%), 1-year composite endpoints were similar. But at 2 years, TAVR was associated with significantly higher stroke (subdistribution HR 3.01, P=0.02) and valve dysfunction (subdistribution HR 4.16, P=0.03). Both guidelines rate TAVI for BAV as Class IIb — and this study reinforces why. Randomized data are urgently needed; encouragingly, a dedicated BAV RCT (NCT07413965) is preparing to launch. (Hemelrijk et al., JAHA)

Swedish national data show post-TAVI stroke declining but still lethal: Among 11,957 TAVI patients (2008–2023), 30-day stroke fell from 5.3% to 3.2%, partly driven by lower-risk patient selection. But stroke remained strongly associated with excess mortality. Self-expanding valves and porcelain aorta were associated with higher stroke probability. (Louca et al., Heart)

Balloon-expandable vs. self-expanding valves in low-flow, low-gradient AS: In 1,380 patients across 17 Italian centers, BEVs showed higher mean gradients, more predicted patient-prosthesis mismatch, and — critically — a 54% higher hazard of heart failure hospitalization at 1 year (HR 1.54, 95% CI 1.05–2.25) versus SEVs. Mortality was similar. This is signal, not noise, for a vulnerable hemodynamic phenotype where every mmHg of residual gradient matters. (Ferruzzi et al., JAHA)

Moderate AS at CABG — to replace or not? An STS database analysis of 18,247 patients ≥65 years found that CABG+SAVR had higher operative mortality but similar mid-term survival to isolated CABG. However, isolated CABG patients faced a 25.9% rate of AV intervention by 8 years (vs. 2.4%). The TAVR backstop changes this equation, but the authors rightly note that deferred intervention means deferred prosthetic degeneration — an underappreciated benefit. (Yu et al., Ann Thorac Surg)

Aortic Valve (TAVR/TAVI)

Updated Meta-Analysis: TAVR vs. SAVR in Low-Risk Patients

Jarade and colleagues from McGill updated their 2019 systematic review, now incorporating 5 RCTs (n=4,532) including PARTNER 3, Evolut Low Risk, DEDICATE, NOTION 2, and UK TAVI. The headline: TAVR reduced 30-day all-cause mortality by 55% (RR 0.45), but at ≥5 years, the mortality curves converge completely (RR 0.99, 95% CI 0.72–1.35). The signal for higher pacemaker rates with TAVR (RR 3.10 at 30 days) persisted. This is the most comprehensive low-risk meta-analysis to date and should temper enthusiasm for expanding TAVR to younger populations without long-term durability assurance. An accompanying editorial by Di Pietro et al. strikes a similar note, emphasizing "remaining uncertainties." Both papers are essential reading for Heart Teams navigating the ESC's lowered age threshold of 70. Full text (Jarade et al.) | Editorial (Di Pietro et al.)

TAVR in Bicuspid Aortic Stenosis: Multicenter Observational Comparison

Hemelrijk et al. present the largest propensity-matched comparison of TAVR vs. SAVR in bicuspid AS to date (997 patients, 256 matched pairs, median age 75). At 1 year, the composite primary endpoint was similar (15.0% TAVR vs. 12.0% SAVR, HR 1.35, P=0.23). However, the 2-year signal is concerning: TAVR had a 3-fold higher stroke hazard and 4-fold higher valve dysfunction hazard. These findings are consistent with known BAV challenges for TAVR — asymmetric calcification, eccentric deployment, incomplete expansion — and with the small BAV subgroup from NOTION 2. Both ACC/AHA 2020 and ESC 2025 appropriately classify TAVI for BAV as Class IIb. The forthcoming randomized trial from Cedars-Sinai (NCT07413965, 1,200 patients) cannot come soon enough. Full text

TAVR in Bicuspid Mixed Aortic Valve Disease

In a separate Chinese cohort of 282 patients with mixed aortic valve disease (concurrent AS and AR), Tang et al. compared TAVR outcomes between bicuspid (n=82) and tricuspid (n=200) morphologies. After propensity matching, technical success and 1-year mortality were equivalent, though BAV patients had more paravalvular leak. Interestingly, BAV patients showed greater LVEF improvement but less reverse remodeling (less reduction in LV dimensions). This suggests distinct ventricular recovery phenotypes that merit further study. Notably, this is a single-country retrospective cohort with short follow-up — interpret cautiously. Full text

Post-TAVI Stroke: Swedish National Registry

Louca et al. analyzed all 11,957 TAVI patients in Sweden (2008–2023) via the SWEDEHEART registry. The 30-day stroke rate was 3.1% overall, declining from 5.3% early in the experience to 3.2% by 2023 (OR 0.97 per year). The decline was partly explained by evolving case-mix (lower EuroSCORE II over time) rather than purely procedural improvements — a nuance that matters. Prior stroke, female sex, porcelain aorta, and self-expanding valves were associated with higher stroke risk; TAVI-in-SAVR was associated with lower risk. Most importantly, post-TAVI stroke carried a stark mortality penalty. The cerebral embolic protection debate remains unresolved, and these data underscore its urgency. Full text

BEV vs. SEV in Low-Flow, Low-Gradient AS

This Italian multicenter registry (17 centers, 1,380 patients, 2019–2024) is the largest dedicated comparison of balloon-expandable vs. self-expanding prostheses specifically in LFLG-AS. After propensity score weighting, 1-year mortality and stroke were similar, but BEV use was associated with a 54% higher risk of heart failure hospitalization (adjusted HR 1.54, 95% CI 1.05–2.25), driven by higher residual gradients and more frequent predicted patient-prosthesis mismatch. For the LFLG phenotype — where cardiac output is already compromised — these hemodynamic differences matter clinically. This adds to the growing literature favoring supra-annular self-expanding designs in small annuli and low-flow states. Limitations: observational design, potential confounding by indication, and no core lab adjudication of hemodynamics. Full text

Moderate AS at Time of CABG: The TAVR Safety Net Question

Yu et al. examined the STS database (2011–2022), comparing 9,325 patients who received CABG+SAVR with 8,922 who had isolated CABG, all with moderate AS and age ≥65. Isolated CABG had lower operative mortality and complications, but at 8 years, 25.9% of CABG-alone patients required subsequent AV intervention (vs. 2.4% with upfront SAVR). Mid-term all-cause mortality was similar. The authors frame this as a question of optimal timing in the TAVR era: if future AS can be treated transcatheter, is the added surgical risk of concomitant SAVR justified? Both current guidelines recommend consideration of concomitant SAVR for moderate AS during other cardiac surgery (Class IIa) — but this study highlights the evolving calculus. A key counterargument: delaying prosthetic implantation also delays prosthetic degeneration and its associated reintervention burden. Full text

Redo TAVR: CT Simulation in Asian Patients

Ochiai et al. simulated SAPIEN 3-in-Evolut implantation using post-procedural CT in 113 Asian patients. The results are sobering: at high implantation depth, 63.7% of patients had severe geometric coronary constraint. Even at intermediate depth, 31.0% were classified as severe. Smaller sino-tubular junction diameter was independently associated with severe constraint. Asian patients with characteristically smaller aortic roots may face disproportionate coronary access challenges with redo TAVR — a critical consideration as "lifetime management" planning enters mainstream guidelines (ESC 2025). Full text

LV Remodeling After Redo TAVR

Onishi et al. present a first-in-human CT analysis of left ventricular remodeling after redo TAVR. No abstract is available yet, but this addresses a critical knowledge gap: how does valve-in-valve hemodynamic performance translate to reverse remodeling? Given the known risks of patient-prosthesis mismatch with TAV-in-TAV (flagged prominently in ESC 2025 lifetime management recommendations), imaging data from this population are highly relevant. Full text

Novel Flow Analysis After TAVI

An engineering study from Düsseldorf applies proper orthogonal decomposition (POD) to quantify post-TAVI aortic flow restoration relative to healthy references. In 8 patients, POD-based markers identified clinically relevant groupings better than conventional measures. While the sample is tiny and the method requires validation, this represents the kind of computational hemodynamic assessment that could eventually inform patient-specific procedural optimization. Full text

Mitral Valve (MitraClip, PASCAL, TMVR)

Sex-Specific Outcomes After PASCAL M-TEER: The REPAIR Registry

Von Stein et al. report on 2,601 patients from the multicenter REPAIR registry — the largest sex-stratified analysis of PASCAL M-TEER to date. Technical success was equivalent between women (97.0%) and men (97.7%), and 1-year mortality was similar (~11–12%). However, women achieved an "optimal result" (MR ≤1+ and mean gradient <5 mmHg) less often than men (55.7% vs. 65.9%, P<0.001), driven by higher postprocedural gradients in women (24.0% had gradients ≥5 mmHg vs. 14.0% in men). The clinically important finding: residual MR ≤1+ was independently associated with lower 1-year mortality (adjusted HR 0.57), while gradient <5 mmHg was not a significant independent predictor. This suggests that MR reduction — not gradient optimization — should be the primary procedural target, and that the higher gradient rates in women (likely reflecting smaller mitral anatomy) do not translate to worse outcomes. Nevertheless, the gradient concern deserves longer follow-up: mitral stenosis physiology may become more important with exercise and over time. Full text

Dynamic MR: A POCUS Case Report

A case report from the POCUS Journal describes an elderly patient with recurrent flash pulmonary edema initially attributed to hypertension, where cardiac point-of-care ultrasound identified severe dynamic mitral regurgitation missed on standard TTE. A reminder that MR severity is load-dependent and may be dramatically underestimated on a single resting echocardiogram — a limitation with real implications for surgical and transcatheter referral timing. Full text

Tricuspid Valve (TriClip, TTVR)

CPET Data After Transcatheter Tricuspid Interventions

Cumitini et al. provide the first objective cardiopulmonary exercise testing data for transcatheter tricuspid interventions — a small (n=10) but important prospective study. Patients with severe TR undergoing PASCAL repair or EVOQUE replacement showed significant improvement in peak VO₂ (14.7 to 16.4 mL/kg/min, P=0.009), peak oxygen pulse, and ventilation maximum at 3 months. NYHA class improved and diuretic dose decreased. The sample is tiny, but CPET data matter: they provide objective evidence of functional improvement that complements the patient-reported outcomes driving TRILUMINATE and Tri.Fr. These data align with the ESC 2025 Class IIa recommendation for transcatheter TR treatment in high-risk symptomatic patients. Full text

Coronary Sinus Lead Entrapment During TTVR

A JACC Case Report describes simultaneous fracture of RV and LV leads in a pacing-dependent patient after TTVR, necessitating epicardial pacing. This highlights an underappreciated complication: coronary sinus leads coursing near the tricuspid annulus can be entrapped during valve deployment, not just RV leads. Current guidelines recommend preemptive alternative pacing strategies, but this case shows the risk extends to CRT-D devices with left ventricular leads. Any center performing TTVR in pacing-dependent patients must have a contingency plan. Full text

Surgical vs. Transcatheter Comparisons

Today is unusually rich in TAVR-vs.-SAVR data. The key takeaways across multiple studies:

Low-risk patients (meta-analysis): TAVR wins early, ties late. At ≥5 years, no mortality, stroke, or reintervention differences. Pacemaker rates remain higher with TAVR. (Jarade et al.)
Bicuspid AS (observational): TAVR has equivalent 1-year outcomes but significantly higher 2-year stroke and valve dysfunction. SAVR remains the default for BAV per both guidelines (Class IIb for TAVR). (Hemelrijk et al.)
Moderate AS at CABG: Adding SAVR increases operative risk but dramatically reduces future AV reintervention. The availability of TAVR as a safety net changes the risk-benefit calculus for deferral. (Yu et al.)
Secondary access for TAVI: A randomized trial (NCT06284837) comparing femoral vs. radial secondary access during TAVI is actively recruiting — addressing a procedural detail that affects complication rates.

The recurring theme: TAVR is an extraordinary technology that has transformed care for older, higher-risk patients. But the push toward younger, lower-risk, and anatomically complex populations must be evidence-driven, not enthusiasm-driven. As the accompanying Am J Cardiol editorial notes, these "promising outcomes" come with "remaining uncertainties" — a framing that should guide every Heart Team discussion.

Device & Technology

Abbott introduces TriClip in India. Abbott's tricuspid transcatheter edge-to-edge repair system is now available in India, marking a significant geographic expansion for transcatheter tricuspid therapy. India's large population of rheumatic and functional TR patients — many presenting late with advanced RV dysfunction — represents both an opportunity and a challenge. Whether TRILUMINATE-level outcomes can be replicated in this population, which may differ substantially in etiology and disease severity, will be important to track. (IndiaMedToday)

Anteris expands US trial push for DurAVR. The Australian medtech company, whose TAVR prosthesis uses a single-piece pericardial design shaped to mimic native aortic valve anatomy, is accelerating enrollment in its US pivotal trial. The DurAVR THV system (NCT07194265, enrolling 1,650 patients) is randomizing against SAPIEN and Evolut platforms. Anteris shares surged 11% today. (Kalkine Media)

Scaling heart valve manufacturing in Europe. Engineering firm Jacobs highlights its role in expanding heart valve production capacity across Europe, reflecting growing demand driven by TAVI volume expansion and the aging population. (Jacobs)

TAVR in rural India. An advanced TAVR procedure was performed in Dharampur, Valsad — a small town in Gujarat. This reflects the ongoing geographic democratization of structural heart interventions in emerging markets, though it also raises questions about volume-outcome relationships and post-procedural surveillance infrastructure. (Ahmedabad Mirror)

Industry & Market

Is TAVR too common among younger patients? Cardiovascular Business highlights growing concern about TAVR utilization in younger cohorts where long-term data are limited — echoing the "indication creep" warnings from Badhwar, Mehaffey, Kaul, and others. This dovetails with today's meta-analysis data showing no long-term TAVR advantage, and with the ESC 2025's deliberate decision to keep SAVR as the preferred approach under age 70. (Cardiovascular Business)

TAVR market expansion in Latin America. A market report highlights growth in TAVR adoption across Latin American markets, driven by regulatory approvals, physician training programs, and an aging population with high rheumatic and degenerative valve disease burden. (openPR)

Pregnancy and heart disease in India. The NPAC-India study (56 sites) launches a prospective multicenter registry of pregnant women with cardiovascular disease — including valvular heart disease — to generate locally relevant evidence for this underserved population. Current management guidelines derive almost entirely from high-income country data. (Full text)

Financial Analysis

The structural heart sector is navigating a challenging market environment. Despite robust procedural volumes and expanding indications, major valve industry stocks remain significantly below their 52-week highs, reflecting broader medtech sector headwinds — tariff uncertainty, pricing pressure, and macroeconomic anxiety that has compressed multiples across the space.

Edwards Lifesciences remains the bellwether for structural heart sentiment. Analyst commentary this week focuses on "conservative accounting" that may understate underlying earnings power, and the RESILIA tissue platform's clinical trial momentum is noted as a potential near-term catalyst. With 27 analysts maintaining a consensus "buy" and an average target of $97.15 (19% upside from current levels), the Street sees Edwards as undervalued. The new CFO appointment adds a governance headline. Edwards reports next on July 23 — watch for TAVR volume trends and PASCAL uptake commentary.

Medtronic hired a new chief operations and supply chain officer, signaling focus on manufacturing efficiency as it prepares to report earnings on June 3. The stock is down nearly 19% over six months, underperforming peers. The Evolut platform's competitive position in the LFLG-AS segment (where today's Italian registry data favor self-expanding valves) could be a talking point. The Intrepid TMVR pivotal trial (NCT03242642) continues enrolling — any update would be material.

Abbott has been the worst-performing large-cap in the group (-34% over six months), driven by litigation exposure and broader market concerns. The TriClip India launch is a positive geographic expansion story, and key approvals are being highlighted in industry media. But at $84.90, the stock sits well below its 52-week high of $139. Abbott reports July 16.

Boston Scientific touched a 52-week low this week at $53.10, down 47% over six months. Despite this, analysts maintain a "strong buy" consensus with an average target of $85 — representing 59% upside potential. The cardiovascular segment continues to grow, but the stock has been caught in a sector-wide de-rating. The CLASP II TR pivotal trial (NCT04097145) for the PASCAL system in TR continues to recruit.

Anteris Technologies was the day's standout, surging 11% on news of its US pivotal trial expansion for the DurAVR THV system. At A$9.93, the stock is up 70% over six months from depressed levels, though it remains a high-risk pre-revenue play with a market cap of A$1.0B and no earnings. The single analyst covering the stock has a A$13 target.

Valve Industry Stocks

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

Close: $81.34 | Daily Change: -$0.05 (-0.06%)
6-Month Performance: -$3.40 (-4.01%)
Market Cap: $46.8B | P/E (trailing): 43.97 | P/E (forward): 24.19
Beta: 0.87 | 52-Week Range: $72.30 – $87.89
Analyst Consensus: Buy | Target: $97.15 (range $84–$110, 27 analysts) — 19% upside
Next Earnings: July 23, 2026 | EPS est: $0.74 | Rev est: $1.70B
Commentary: Outperformed competitors on a recent trading day. RESILIA trial success and new CFO appointment noted as positive catalysts. Conservative accounting may understate earnings power. The company's PASCAL platform expansion (including the CLASP II TR and TRISCEND II trials in tricuspid) diversifies beyond TAVR dependence.

Medtronic (MDT)

Close: $76.97 | Daily Change: +$0.76 (+1.00%)
6-Month Performance: -$17.83 (-18.81%)
Market Cap: $98.8B | P/E (trailing): 21.50 | P/E (forward): 12.69
Beta: 0.63 | 52-Week Range: $74.40 – $106.33
Analyst Consensus: Hold | Target: $108.00 (range $90–$121, 25 analysts) — 40% upside
Next Earnings: June 3, 2026 | EPS est: $1.55 | Rev est: $9.62B
Commentary: New chief operations and supply chain officer hired. The Evolut platform may benefit from today's Italian registry data favoring self-expanding valves in LFLG-AS. Intrepid TMVR and Evolut Low Risk long-term follow-up are key pipeline catalysts. Near 52-week low — June 3 earnings will be critical.

Abbott Laboratories (ABT)

Close: $84.90 | Daily Change: +$1.07 (+1.28%)
6-Month Performance: -$43.67 (-33.96%)
Market Cap: $147.9B | P/E (trailing): 23.78 | P/E (forward): 14.00
Beta: 0.65 | 52-Week Range: $81.97 – $139.06
Analyst Consensus: Buy | Target: $118.64 (range $92–$143, 25 analysts) — 40% upside
Next Earnings: July 16, 2026 | EPS est: $1.28 | Rev est: $12.53B
Commentary: TriClip India launch extends tricuspid therapy to a massive market. Key device approvals highlighted in industry press. Significant underperformance over 6 months reflects litigation headwinds beyond the structural heart business. The Cephea mitral valve disease registry (NCT07069673) and MitraClip/TriClip long-term data are structural heart catalysts to watch.

Boston Scientific (BSX)

Close: $53.55 | Daily Change: +$0.49 (+0.92%)
6-Month Performance: -$48.21 (-47.38%)
Market Cap: $79.6B | P/E (trailing): 22.41 | P/E (forward): 14.23
Beta: 0.62 | 52-Week Range: $52.75 – $109.50
Analyst Consensus: Strong Buy | Target: $85.19 (range $60–$110, 32 analysts) — 59% upside
Next Earnings: July 29, 2026 | EPS est: $0.83 | Rev est: $5.40B
Commentary: Hit 52-week low at $53.10 this week. Despite the steep selloff, analysts maintain the most bullish consensus in the group. The cardiovascular segment continues to grow, and the ACURATE neo2 TAVR platform positions BSX in the expanding TAVI market. Near 50% drawdown from highs creates a deep-value argument for long-term holders.

Anteris Technologies (AVR.AX)

Close: A$9.93 | Daily Change: +A$0.99 (+11.07%)
6-Month Performance: +A$4.08 (+69.74%)
Market Cap: A$1.0B | P/E (forward): -4.55 (pre-revenue)
Beta: 0.59 | 52-Week Range: A$4.68 – A$10.00
Analyst Consensus: N/A | Target: A$13.00 (1 analyst) — 31% upside
Commentary: Surged 11% on US pivotal trial expansion news for DurAVR THV system (NCT07194265, 1,650 patients). The single-piece ADAPT tissue design promises improved hemodynamics and durability. Pre-revenue, high-risk/high-reward profile. The stock has nearly doubled from 6-month lows but remains a speculative bet on next-generation TAVR technology.

Note: JenaValve Technology, J Valve Technology, and Meril Life Sciences are private companies with no public stock data available.

Market Outlook: The structural heart industry finds itself in an unusual position: clinical data and procedural volumes continue to strengthen, but stock prices across the sector are depressed by macroeconomic headwinds, tariff concerns, and litigation risk (particularly for Abbott). Forward P/E ratios for Edwards (24x), Medtronic (13x), Abbott (14x), and Boston Scientific (14x) are well below historical averages, suggesting the market is pricing in considerable risk. For investors with a longer time horizon, the sector's fundamentals — aging demographics, expanding indications (tricuspid, asymptomatic AS, TMVR), and geographic expansion into emerging markets — remain compelling. The upcoming earnings cycle (Medtronic June 3, Abbott July 16, Edwards July 23, BSX July 29) will be a critical test of whether current valuations represent opportunity or appropriate caution.

Clinical Trial Updates

Aortic Valve

[LANDMARK] Evolut Low Risk Long-Term Follow-up (NCT02701283) — Status: Active, not recruiting | Enrollment: 2,223 | Sponsor: Medtronic Cardiovascular | The definitive long-term follow-up of the Evolut Low Risk RCT. Data beyond 5 years are critical for informing the ESC's age-70 threshold. Last updated May 7, 2026.
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis (NCT07413965) — Status: Not yet recruiting | Phase: N/A | Enrollment: 1,200 | Sponsor: Cedars-Sinai Medical Center | The first dedicated RCT comparing TAVR and SAVR in BAV. Given today's observational data showing higher 2-year stroke and valve dysfunction with TAVR in BAV, this trial is urgently needed. Last updated May 12, 2026.
DurAVR THV System Pivotal Trial (Anteris) (NCT07194265) — Status: Recruiting | Enrollment: 1,650 | Sponsor: Anteris Technologies | Randomizing DurAVR against SAPIEN and Evolut platforms. The next-generation TAVR contender. Last updated May 11, 2026.
Surgical vs Transcatheter AVR in YOUNG Patients (NCT06861361) — Status: Recruiting | Enrollment: 1,180 | Sponsor: Ceric Sàrl | Randomizing Myval balloon-expandable THV vs. surgical bioprosthetic valves in younger patients — directly addressing the guideline tension point around the 65–70 age range. Last updated May 12, 2026.
REdo TAVI for Transcatheter Aortic Valve Failure (REVALVE) (NCT06557798) — Status: Recruiting | Enrollment: 550 | Sponsor: Leeds Teaching Hospitals NHS Trust | Comparing redo TAVI, surgical explantation, and conservative management for THV failure. A critical lifetime management study. Last updated May 13, 2026.
Post-Dilatation in Balloon-Expandable TAVI Prostheses (NCT07477002) — Status: Recruiting | Enrollment: 146 | Sponsor: Medical University of Vienna | Last updated May 12, 2026.
Secondary Access — Femoral or Radial in TAVI (SAFE-R) (NCT06284837) — Status: Recruiting | Enrollment: 542 | Sponsor: The Alfred | Randomized comparison of secondary access site strategy. Last updated May 14, 2026.
Ticagrelor vs. ASA-Clopidogrel Post-TAVI (NCT02817789) — Status: Completed | Phase: III | Enrollment: 50 | Sponsor: University Hospital Bordeaux | Last updated May 12, 2026.
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR (NCT05804240) — Status: Completed | Enrollment: 67 | Sponsor: Thomas Jefferson University | Last updated May 13, 2026.
NHLBI-Emory Advanced Cardiac CT Reconstruction (NCT05372627) — Status: Not yet recruiting | Enrollment: 1,000 | Sponsor: NHLBI | Advanced CT imaging research relevant to TAVR planning. Last updated May 14, 2026.

Mitral Valve — Repair

[LANDMARK] REPAIR-MR (MitraClip vs. Surgery for Primary MR) (NCT04198870) — Status: Active, not recruiting | Enrollment: 500 | Sponsor: Abbott Medical Devices | The pivotal head-to-head trial comparing MitraClip to surgical repair for degenerative MR. Results will directly inform the ESC/ACC debate about TEER's role in primary MR. Last updated November 12, 2025.
[LANDMARK] PRIMATY (MitraClip vs. Medical Therapy for Secondary MR) (NCT05051033) — Status: Recruiting | Enrollment: 450 | Sponsor: Annetine Gelijns | Testing TEER vs. surgery for secondary MR — a different question from COAPT. Last updated March 3, 2026.
[LANDMARK] COAPT Long-Term Follow-up (NCT03706833) — Status: Active, not recruiting | Enrollment: 1,247 | Sponsor: Edwards Lifesciences | Now includes both PASCAL and MitraClip arms. Extended follow-up will inform durability of the ESC's Class I recommendation for TEER in ventricular SMR. Last updated April 9, 2026.
PASCAL Precision-GDMT Registry (NCT07578129) — Status: Not yet recruiting (NEW) | Enrollment: 50 | Sponsor: Ceric Sàrl | A small registry examining PASCAL Precision alongside GDMT optimization. Last updated May 13, 2026.

Mitral Valve — Replacement

[LANDMARK] Intrepid TMVR Pivotal (NCT03242642) — Status: Recruiting | Enrollment: 1,056 | Sponsor: Medtronic Cardiovascular | The largest transcatheter mitral valve replacement trial. Outcome data will be pivotal for defining TMVR's role vs. TEER and surgery. Last updated May 5, 2026.
Abbott Cephea Mitral Valve Disease Registry (NCT07069673) — Status: Recruiting | Enrollment: 1,000 | Sponsor: Abbott Medical Devices | Post-market registry for Abbott's Cephea TMVR system. Last updated May 12, 2026.

Tricuspid Valve — Repair

[LANDMARK] TRILUMINATE Pivotal (TriClip for TR) (NCT03904147) — Status: Active, not recruiting | Enrollment: 572 | Sponsor: Abbott Medical Devices | The foundational trial behind the ESC 2025 Class IIa recommendation for transcatheter TR treatment. Longer-term follow-up is eagerly awaited. Last updated December 19, 2024.
[LANDMARK] CLASP II TR (PASCAL for TR) (NCT04097145) — Status: Recruiting | Enrollment: 1,270 | Sponsor: Edwards Lifesciences | The PASCAL system's pivotal TR trial. With TRILUMINATE data in hand, CLASP II TR will establish whether PASCAL can match or exceed TriClip outcomes. Last updated May 8, 2026.
TriClip Post-Market Assessment (NCT07586995) — Status: Enrolling by invitation (NEW) | Enrollment: 1,000 | Sponsor: Abbott Medical Devices | Post-market safety and performance assessment following commercial approval. Last updated May 14, 2026.
DUO System for Tricuspid Regurgitation (CroiValve) (NCT05913908) — Status: Recruiting | Enrollment: 15 | Sponsor: CroiValve Limited | Early feasibility study of a novel transcatheter tricuspid coaptation valve. Last updated May 13, 2026.

Tricuspid Valve — Replacement

[LANDMARK] TRISCEND II (Evoque Tricuspid Replacement) (NCT04482062) — Status: Active, not recruiting | Enrollment: 864 | Sponsor: Edwards Lifesciences | The definitive tricuspid valve replacement trial. Today's JACC case report on coronary sinus lead entrapment during TTVR underscores the importance of this trial's safety data for pacing-dependent patients. Last updated February 27, 2026.
Cardiovalve TARGET 2.0 Study (NCT07334691) — Status: Recruiting | Enrollment: 150 | Sponsor: Cardiovalve Ltd. | Next iteration of the Cardiovalve TR replacement platform. Last updated May 11, 2026.
Cardiovalve TARGET Study (NCT05486832) — Status: Active, not recruiting | Enrollment: 157 | Sponsor: Cardiovalve Ltd. | Last updated May 11, 2026.
Cardiovalve Early Feasibility Study (NCT04100720) — Status: WITHDRAWN | Enrollment: 0 | Sponsor: Cardiovalve Ltd. | This early feasibility study has been withdrawn, though the company's later-stage TARGET studies continue. Last updated May 11, 2026.
Transcatheter Tricuspid Valved Stent Graft in Carcinoid Heart Disease (NCT05064514) — Status: Active, not recruiting | Enrollment: 15 | Sponsor: Queen Mary University of London | A niche but important application of transcatheter TV replacement. Last updated May 8, 2026.

Heart Failure / Other Relevant Trials

Finerenone in HFmrEF/HFpEF (NCT07583173) — Status: Not yet recruiting | Phase: IV | Enrollment: 104 | Sponsor: China National Center for Cardiovascular Diseases | CMR-based assessment of myocardial fibrosis — relevant to functional MR/TR management. Last updated May 13, 2026.

Social & Conference Highlights

Cardiovascular Business is running three converging stories today that capture the field's mood: concern about TAVR overuse in younger patients, Abbott's device approvals (including TriClip), and SCAI's initiative to study women in the cath lab. The latter resonates with today's REPAIR registry data showing sex-specific differences in PASCAL M-TEER outcomes — a reminder that device performance and patient anatomy interact in ways we're only beginning to characterize systematically.

The ongoing Edwards Lifesciences narrative — RESILIA trial success, new CFO, analyst bullishness — suggests the market sees the company navigating regulatory and competitive headwinds more effectively than peers. Whether that translates to stock performance will depend on upcoming earnings and late-breaking trial data through the second half of 2026.

Today's data collectively make a strong case for scientific humility in structural heart disease. TAVR is a transformative technology — but the long-term convergence with SAVR outcomes in low-risk patients, the persistent BAV challenge, and the hemodynamic nuances between valve platforms all argue against a one-size-fits-all approach. The Heart Team isn't a regulatory formality; it's a clinical necessity. Tomorrow, we'll be watching for Medtronic's earnings preview and any late-breaking updates from the ongoing TAVI trials in younger and bicuspid populations.

— E. Nolan Beckett, The Valve Wire

← May 7, 2026