Tuesday, April 14, 2026 | The Valve Wire

Executive Summary

Today's biggest story comes from JAMA: the first large-scale real-world registry analysis of the Edwards EVOQUE transcatheter tricuspid valve replacement (TTVR) system shows strong early results across 1,034 U.S. patients — confirming the safety and effectiveness signals seen in the TRISCEND II pivotal trial and giving clinicians the first broad look at how this new device performs outside of controlled study conditions. Meanwhile, a new analysis from Annals of Thoracic Surgery reveals troubling hospital-level variation in TAVR use among patients under 65, raising questions about guideline adherence in younger patients where surgery is the recommended approach. On the market front, Edwards Lifesciences reports next week — and its stock is drawing both bullish upgrades and a Mizuho price target cut, reflecting the tension between near-term TTVR momentum and broader valuation concerns.

For the clinical audience: this is a day to focus on the tricuspid space. The STS/ACC TVT Registry data in JAMA (Makkar et al.) represents the most comprehensive real-world snapshot of TTVR we've seen to date — 82 centers, >1,000 patients, 98.4% procedural success, 97.7% achieving mild-or-less TR at 30 days. But pacemaker rates of 15.9% in CIED-naïve patients and 7.9% bleeding deserve scrutiny. Meanwhile, Glance et al. in Annals shine a light on an uncomfortable truth: some hospitals are performing TAVR in patients under 65 at rates that appear inconsistent with both ACC/AHA and ESC guideline recommendations for SAVR in younger patients. Taken together, today's data illustrate both the promise and the pitfalls of the transcatheter revolution — real advances in tricuspid disease meeting real concerns about indication creep in aortic disease.

Today's Key Findings

[NOTABLE] JAMA — Real-World EVOQUE TTVR Registry (Makkar et al.): Among 1,034 attempted procedures at 82 U.S. centers from the STS/ACC TVT Registry, TTVR achieved 98.4% implant success, 97.7% achieving mild-or-less TR at 30 days, 3.1% all-cause mortality, and a 22.4-point KCCQ-OS improvement. These results closely mirror the TRISCEND II pivotal trial and validate the device's real-world performance. However, the 15.9% new CIED rate in pacemaker-naïve patients and 7.9% bleeding events warrant ongoing vigilance. Read the full study

[NOTABLE] Annals of Thoracic Surgery — Hospital-Level TAVR Variation in Patients <65 (Glance et al.): This analysis documents significant hospital-level variation in the use of TAVR versus SAVR among patients younger than 65 — a population where both the 2020 ACC/AHA guidelines (Class I for SAVR under 65) and 2025 ESC/EACTS guidelines (SAVR preferred under 70 at low surgical risk) recommend surgery. This is exactly the kind of indication creep that critics like Bowdish, Badhwar, and Kaul have warned about. Read the full study

Tricuspid Valve (TriClip, TTVR)

JAMA: Real-World Outcomes of Transcatheter Tricuspid Valve Replacement — STS/ACC TVT Registry

This is the study of the day. Makkar et al. report 30-day outcomes from every consecutive TTVR performed with the Edwards EVOQUE system in the United States from February 2024 through March 2025 — capturing the full commercial launch experience. The population was elderly (mean age 77.1), predominantly female (69.1%), and sick (73.2% NYHA III/IV). Key results:

Procedural success: 98.4% (1,017 of 1,034 attempted)
TR reduction: Mild or less in 98.4% post-procedure, 97.7% at 30 days
All-cause death at 30 days: 3.1%
Stroke: 0.2%
Bleeding: 7.9%
New CIED in pacemaker-naïve patients: 15.9%
HF hospitalization at 30 days: 3.1%
KCCQ-OS improvement: +22.4 points (clinically meaningful threshold typically ≥5 points)
NYHA class I/II at 30 days: 82.7% (vs. 26.8% at baseline)

Editorial perspective: These are genuinely encouraging data. The consistency with TRISCEND II outcomes is reassuring — real-world registries often show worse results than pivotal trials due to less restrictive patient selection and a broader range of operator experience. The 15.9% new pacemaker rate deserves attention; it was actually lower than in the RCT, which is noteworthy. The bleeding rate of 7.9% was also lower than trial experience. However, several caveats apply: (1) 30-day follow-up is very short for a permanent implant; we need 1-year and longer data to assess durability, late thrombosis, and sustained functional benefit; (2) patient selection in the early commercial phase may still be conservative, enrolling "ideal" anatomies and experienced centers; (3) the comparison arm here is a registry, not randomized controls — we cannot draw causal inferences about superiority to medical therapy from these data alone. That said, combined with TRISCEND II, TRILUMINATE, and Tri.Fr, the ESC's 2025 upgrade of transcatheter tricuspid therapy to Class IIa appears well-supported by accumulating evidence.

PMID: 41973411

Aortic Valve (TAVR/TAVI)

Hospital-Level Variation in TAVR vs. SAVR Among Patients Under 65

Glance et al., writing in Annals of Thoracic Surgery, document substantial variation across hospitals in the proportion of patients under 65 years with isolated aortic stenosis who receive TAVR versus SAVR. This is a critical finding because both major guidelines agree that surgery is the preferred treatment in this age group. The ACC/AHA 2020 guidelines recommend SAVR as Class I for patients under 65; the ESC 2025 guidelines recommend SAVR for patients under 70 at low surgical risk. TAVR's evidence base in younger patients is thin — these individuals were underrepresented in all major randomized trials (PARTNER 3, Evolut Low Risk, DEDICATE), and long-term durability data beyond 10 years remain unavailable.

Editorial perspective: This paper joins a growing literature on indication creep in TAVR, echoing concerns raised by Bowdish et al. ("From the Hazards of Death to the Hazards of Indication Creep for TAVR") and others. The variation is the tell: if the evidence clearly supported TAVR in younger patients, we would expect convergence, not divergence. Instead, we see some hospitals performing TAVR in this age group at far higher rates than others — suggesting that institutional culture, reimbursement incentives, or patient request may be driving decisions more than evidence. The lifetime management implications are profound: a 55-year-old receiving TAVR today faces likely reinterventions, with TAVR explant carrying 12-17% mortality and valve-in-valve procedures introducing additional risks (coronary obstruction, patient-prosthesis mismatch). This is a paper that every Heart Team should discuss.

Read the full article

Cost-Effectiveness of TAVR in Younger Patients (Ages 60-75) — German EHR Analysis

Kaier et al. analyzed 28,805 German patients undergoing isolated SAVR or TF-TAVR (2018-2022) using a debiased machine learning approach. TAVR was associated with lower in-hospital mortality (RR 0.65), less bleeding, less delirium, and shorter ventilation — but cost €7,071 more per case, yielding an ICER of €857,413 per life saved from the in-hospital perspective and €196,422 from a 1-year perspective. The authors note the cost gap is narrowing as TAVR reimbursement decreased ~12% over the study period.

Editorial perspective: This is a thoughtful analysis, but several limitations temper enthusiasm. It is observational and retrospective, subject to unmeasured confounders despite sophisticated machine learning adjustment. The age range (60-75) includes patients for whom both guidelines prefer SAVR, and applying short-term cost-effectiveness to a treatment with uncertain long-term durability is methodologically fraught. The authors themselves concede that life expectancy of 11-25 years in this group means durability matters enormously — precisely the data point we lack. Notably, the in-hospital ICER of €857,413 far exceeds any conventional willingness-to-pay threshold; only the 1-year extrapolation makes the case plausible. This is useful health economic modeling, but it should not be interpreted as justifying expanded TAVR use in younger patients without long-term outcome data.

PMID: 41973212

Double-Tap Technique Under Pressure-Sensing Guidewire Guidance — JACC Case Reports

Nishimura et al. report a case series of 6 patients undergoing TAVR with balloon-expandable valves in whom the "double-tap technique" (repeat post-dilation with the original delivery balloon at the same volume) was performed with real-time hemodynamic assessment via pressure-sensing guidewire. The technique significantly reduced mean transvalvular gradients (median -6.5 mmHg) and increased THV diameter (median +0.8 mm), with paravalvular leak reduced to trivial/none in all patients and no adverse events at 30 days.

Caveat: N=6, single-center, no control group. Interesting proof of concept for precision post-dilation, but far from practice-changing.

PMID: 41973885

SGLT-2 Inhibitors and AKI After TAVI

Keskin et al. report that pre-procedural SGLT-2 inhibitor use was associated with significantly reduced AKI after TAVI in a single-center registry of 532 patients (4.5% vs. 16.0% AKI, P<0.001), particularly in patients with CKD. Results held after propensity score matching.

Editorial note: Single-center, retrospective, relatively small sample. The effect size is large and biologically plausible given known nephroprotective mechanisms of SGLT-2i, but confounding by indication (healthier patients may be more likely to be on SGLT-2i) is a concern. Worth monitoring for larger, ideally prospective or randomized confirmation.

PMID: 41969667

BEV vs. SEV in Bicuspid Aortic Valve TAVR — Meta-Analysis

Maloth et al. pooled 9 observational studies comparing balloon-expandable (BEV) and self-expandable (SEV) valves for TAVR in BAV stenosis. No significant difference was found in mortality, stroke, AKI, or moderate/severe paravalvular leak. BEVs were associated with lower rates of pacemaker implantation and second valve deployment.

Perspective: All observational data, and BAV remains a Class IIb indication for TAVR in both guidelines. NOTION 2 showed a numerically higher event rate with TAVI in BAV patients. This meta-analysis does not change the calculus: BAV patients who are reasonable surgical candidates should still be directed toward SAVR, especially if young or with coexistent aortopathy.

PMID: 41970543

Additional TAVR Studies

Malnutrition + sarcopenia after TAVR: In 340 patients, coexisting malnutrition (GNRI <98) and sarcopenia (SPPB ≤9) conferred a 3.15-fold higher risk of all-cause death post-TAVR. Neither condition alone reached significance. Reinforces the importance of multimodal frailty assessment. PMID: 41970481
Left axis deviation in post-TAVR LBBB: Among 254 patients with new-onset LBBB after TAVR, those with left axis deviation (38%) had higher pacemaker implantation rates at 3 years (16% vs. 6%) but no difference in mortality or HF hospitalization. May warrant closer monitoring. PMID: 41970477
Right trans-subclavian TAVI: Small series (22 patients) showing feasibility but a larger device-annulus angle and 9.1% symptomatic stroke rate — concerning, though not statistically significant given the small sample. PMID: 41970484
Urgent TAVI — valve type editorial: Zheng and Cheng in International Journal of Cardiology comment on whether valve type matters in urgent TAVR. No abstract available. PMID: 41974377
Heyde-like syndrome post-TAVI: Case report of massive GI bleeding from gastric angiodysplasia in an elderly TAVI patient — a reminder to screen for Heyde syndrome in TAVI candidates with unexplained anemia. PMID: 41970306

Mitral Valve (MitraClip, PASCAL, TMVR)

Colombian MitraClip Experience — 94 Patients Over 9 Years

Melo-Burbano et al. report outcomes from the first 94 patients treated with MitraClip in Colombia (2013-2022). The population was predominantly functional MR (93.6%), NYHA III/IV (90.4%), with a mean age of 70.3. Procedural success (MR ≤ moderate) was 93.6%. In-hospital mortality was 2.1%; 1-year mortality, 16%; 2-year mortality, 20.2%. HF rehospitalization occurred in 39.4%. De novo AF was the most common complication (7.4%).

Perspective: These are real-world outcomes from a resource setting that doesn't often appear in the TEER literature. The mortality figures are consistent with — or slightly higher than — COAPT and European registries, which may reflect the predominantly functional MR population and high-risk profile. The 39.4% HF rehospitalization rate underscores that TEER is not curative in ventricular SMR; it requires ongoing GDMT optimization. Notably, this cohort preceded the strict COAPT-like patient selection criteria now codified in the ESC 2025 guidelines (Class I for TEER in ventricular SMR meeting specific criteria).

PMID: 41973195

Venous Tissue Dissection During MitraClip — Rare Complication Report

Ouyang et al. describe a case of venous tissue dissection during MitraClip, a rare but important complication to recognize. The authors aim to raise awareness for diagnosing newly formed abnormal structures in the central atrium during the procedure.

PMID: 41975242

Transatrial TMVR for Severe Mitral Annular Calcification — Mayo Clinic Series

Curran et al. report 25 patients with severe MAC who underwent transatrial TMVR with a balloon-expandable prosthesis (SAPIEN 3 in 24 cases) at Mayo Clinic (2014-2024). This was a very high-risk cohort (median STS-PROM 9%, 48% prior cardiac surgery, 76% NYHA III/IV). Operative mortality was 12%, and 1-, 3-, and 5-year survival was 68%, 59.5%, and 50.6%. Concomitant procedures were performed in 68%. Six patients had paravalvular leak; three underwent successful transcatheter closure.

Editorial perspective: Severe MAC remains one of the most challenging problems in valve surgery. These results are acceptable given the risk profile, but 12% operative mortality and 50.6% 5-year survival remind us that this is a palliative rather than curative intervention. The ESC 2025 guidelines rate TMVI for degenerative MS with MAC as Class IIb at experienced centers — these data support that cautious recommendation. This is a niche but important use case for hybrid surgical-transcatheter approaches.

PMID: 41971890

Bailout Open-Heart TMVR for Extensive Calcification

Verolino et al. describe a haemodialysis patient with triple severe valvular disease and extensive intracardiac calcification who underwent successful triple-valve surgery with a bailout transatrial transcatheter mitral valve implantation to avoid dangerous decalcification. A reminder of the creative hybrid approaches possible when conventional surgical techniques are precluded.

PMID: 41972247

Surgical vs. Transcatheter Comparisons

Two studies today directly address the SAVR-versus-TAVR debate:

Glance et al. (Annals of Thoracic Surgery): Hospital-level variation in TAVR use among patients under 65 — where guidelines uniformly favor SAVR — represents a systems-level challenge to appropriate patient selection. Full text
Kaier et al. (Clinical Research in Cardiology): German cost-effectiveness analysis showing TAVR's short-term clinical advantages in patients aged 60-75, but at substantially higher cost and without long-term durability data. PMID: 41973212

Read together, these papers capture the central tension in contemporary aortic valve therapy: TAVR delivers excellent short-term results with lower procedural morbidity, but the 2020 ACC/AHA (<65) and 2025 ESC (<70) guidelines continue to prefer SAVR in younger patients for good reason — durability uncertainty, lifetime management complexity, and the absence of randomized long-term data in this age group. Hospital-level variation suggests the guidelines may not be uniformly influencing practice.

Device & Technology

AI-ECG + Handheld Ultrasound for Structural Heart Screening

Schlesinger et al. evaluated a stepwise screening strategy — AI-enabled ECG followed by novice-performed handheld cardiac ultrasound (HCU) — for detecting aortic stenosis, increased LV wall thickness, and LV systolic dysfunction in 286 patients. The stepwise approach reduced cost per diagnosis by 19.1% overall (57% savings for AS specifically) by avoiding unnecessary TTEs after false-positive AI-ECG screens.

Commentary: Population-based SHD screening remains controversial because it hasn't been shown to improve outcomes, and the downstream costs of false positives and overdiagnosis are real. But this cost-modeling study suggests the economics could become favorable — particularly for AS detection in aging populations where early TAVR is now an ESC Class IIa recommendation for asymptomatic severe disease. The combination of AI-ECG with novice-operated point-of-care ultrasound is a scalable model worth watching.

PMID: 41970469

FDA Clears AI for Cardiac Amyloidosis Detection

Cardiovascular Business reports the FDA has cleared an AI tool for detecting cardiac amyloidosis — a critical diagnostic advance given that cardiac amyloidosis is a treatable cause of aortic stenosis and heart failure that remains underdiagnosed. Early identification can fundamentally alter management, including decisions about TAVR candidacy and the appropriateness of valve intervention.

Read at Cardiovascular Business

Financial Analysis

The structural heart sector enters a pivotal week. Edwards Lifesciences reports Q1 earnings on April 22, with consensus estimates of $0.73 EPS on $1.60B revenue. Today's JAMA publication of the EVOQUE TTVR registry data is a well-timed tailwind — demonstrating that the commercial launch is translating into real-world outcomes consistent with pivotal trial data. The 1,034 procedures across 82 centers in just 13 months of commercial availability signals robust early adoption.

However, the investment picture is mixed. Mizuho lowered its Edwards price target from $100 to $95, even as other analysts maintain bullish stances — reflecting uncertainty about whether TTVR revenues can offset slowing growth in the maturing TAVR franchise, particularly amid pricing headwinds in Europe (German TAVR reimbursement dropped 12% over 2018-2022 per the Kaier analysis). Baillie Gifford's sale of 55,936 Edwards shares adds a cautious institutional signal ahead of earnings. Boston Scientific also reports on April 22, while Abbott reports on April 16 — all three major structural heart players reporting within a single week.

The broader medtech sector is under pressure, with Abbott and Boston Scientific both down substantially over 6 months (-23.7% and -34.4% respectively), reflecting macro headwinds rather than structural heart-specific concerns. The VDyne TRIVITA Pivotal trial enrollment (see Clinical Trial Updates below) introduces a new competitive dimension in the TTVR space — potentially challenging Edwards' first-mover advantage with the EVOQUE. Edwards' ability to demonstrate durability and expand indications will be key to maintaining its lead as competitors enter the market.

Valve Industry Stocks

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

Close: $78.12 (+$0.25, +0.32%)
6-Month Performance: +6.49% (+$4.76)
Market Cap: $45.4B | P/E (trailing): 43.16 | P/E (forward): 23.52 | Beta: 0.94
52-Week Range: $68.63 - $87.89
Analyst Consensus: Buy | Target: $96.78 (range: $84-$110, 27 analysts)
Next Earnings: April 22, 2026 (EPS est: $0.73 | Rev est: $1.60B)

Edwards is the structural heart pure-play to watch this week. The JAMA EVOQUE registry data validates the commercial TTVR launch, but the stock remains well below analyst targets. Mizuho's target cut ($100→$95) introduces a note of caution ahead of earnings, while Baillie Gifford's 55,936-share sale suggests some institutional repositioning. Forward P/E of 23.5x is reasonable for medtech, but sustained TTVR adoption and PASCAL/MitraClip competitive dynamics will drive the multiple. Key earnings question: how fast is the TTVR ramp relative to guidance, and what does TAVR volume growth look like in the face of European pricing pressure?

Medtronic (MDT)

Close: $88.00 (+$0.79, +0.91%)
6-Month Performance: -7.43% (-$7.06)
Market Cap: $113.0B | P/E (trailing): 24.58 | P/E (forward): 14.52 | Beta: 0.76
52-Week Range: $79.93 - $106.33
Analyst Consensus: Buy | Target: $109.56 (range: $91-$125, 25 analysts)
Next Earnings: June 3, 2026 (EPS est: $1.54 | Rev est: $9.63B)

Medtronic's structural heart story centers on the Evolut FX+ platform and the Intrepid TMVR system (currently recruiting for its pivotal trial). The Evolut Low Risk long-term follow-up trial (NCT02701283) remains active and will provide critical durability data. At a forward P/E of 14.5x, MDT trades at a substantial discount to Edwards, reflecting its diversified business but also muted structural heart growth expectations. The PERFECT registry (Evolut FX+ in Portugal) and broader Evolut franchise performance will be key watch items.

Abbott (ABT)

Close: $100.69 (+$0.39, +0.39%)
6-Month Performance: -23.73% (-$31.32)
Market Cap: $175.0B | P/E (trailing): 27.07 | P/E (forward): 16.49 | Beta: 0.78
52-Week Range: $99.05 - $139.06
Analyst Consensus: Buy | Target: $131.44 (range: $113-$158, 25 analysts)
Next Earnings: April 16, 2026 (EPS est: $1.15 | Rev est: $11.00B)

Abbott reports Wednesday — the first of the big three structural heart companies. Its structural heart portfolio spans TriClip (TRILUMINATE), MitraClip, and the Navitor TAVR platform. ABT sits near its 52-week low at $100.69, creating a compelling valuation gap vs. analyst targets (~30% upside to consensus). The TRILUMINATE Pivotal trial remains active but not recruiting, with 2-year data having already supported the ESC 2025 Class IIa recommendation for transcatheter tricuspid repair. Wednesday's call should reveal TriClip commercial trajectory and MitraClip volume trends following the ESC's Class I upgrade for TEER in ventricular SMR. The REPAIR-MR trial (MitraClip vs. surgery for primary MR) is now active but not recruiting, with results eagerly awaited.

Boston Scientific (BSX)

Close: $63.18 (+$1.39, +2.25%)
6-Month Performance: -34.35% (-$33.06)
Market Cap: $93.9B | P/E (trailing): 32.57 | P/E (forward): 16.20 | Beta: 0.78
52-Week Range: $60.59 - $109.50
Analyst Consensus: Strong Buy | Target: $98.72 (range: $69-$124, 32 analysts)
Next Earnings: April 22, 2026 (EPS est: $0.79 | Rev est: $5.18B)

Boston Scientific has been hit hardest among the large-cap medtech names, down over 34% in six months and sitting near its 52-week low. Despite the drawdown, BSX maintains the strongest analyst consensus (Strong Buy) and the widest gap between current price and consensus target (~56% upside). Its structural heart footprint is smaller than peers, but the company's broader interventional cardiology platform and strong execution history keep it on the radar. Earnings April 22 alongside Edwards will provide a useful same-day comparison.

Anteris Technologies (AVR.AX)

Close: A$8.45 (+A$0.65, +8.33%)
6-Month Performance: +23.72% (+A$1.62)
Market Cap: A$0.8B | Forward P/E: -3.88 (pre-revenue) | Beta: 0.55
52-Week Range: A$4.26 - A$9.79
Analyst Target: A$13.00 (1 analyst)

Anteris was the standout performer today (+8.33%), continuing its upward trajectory as the DurAVR THV System advances through clinical development. The early feasibility study (NCT05712161) is now complete, and the larger pivotal trial (NCT07194265, 1,650 patients, comparing DurAVR to SAPIEN and Evolut) is actively recruiting. Anteris remains a pre-revenue, high-risk bet on next-generation single-piece TAVR technology — intriguing, but investors should note the razor-thin trading volume (8,443 shares) and single-analyst coverage.

Note: JenaValve Technology, J Valve Technology, and Meril Life Sciences are private companies without public stock data. JenaValve is sponsoring the ARTIST trial (see below), a major randomized study of TAVR for aortic regurgitation — a potentially transformative indication expansion.

Market Outlook: The structural heart sector enters its most consequential earnings week of the quarter with all three major players reporting within days. Abbott (April 16), Edwards (April 22), and Boston Scientific (April 22) will collectively reveal whether the post-ESC 2025 guideline expansion — TEER to Class I for ventricular SMR, tricuspid therapy to Class IIa — is translating into commercial volume acceleration. The JAMA TTVR registry publication positions Edwards favorably, but the broader medtech selloff (ABT -24%, BSX -34% over 6 months) suggests macro concerns dominate sector-specific catalysts. Watch for commentary on European vs. U.S. growth divergence, TAVR pricing trends, and the competitive landscape as VDyne and others enter the tricuspid space.

Clinical Trial Updates

Aortic Valve Trials

[LANDMARK] Evolut Low Risk — Long-Term Follow-Up (NCT02701283) — Status: ACTIVE, NOT RECRUITING | Enrollment: 2,223 | Sponsor: Medtronic Cardiovascular | This pivotal trial's extended follow-up is among the most important datasets in structural heart disease. Long-term durability outcomes comparing Evolut TAVR to SAVR in low-risk patients will directly inform the next ACC/AHA guideline update. Last updated: March 19, 2026.
ARTIST: Aortic Regurgitation Trial Investigating Surgery vs. Trilogy™ (NCT06608823) — Status: RECRUITING | Enrollment: 1,016 | Sponsor: JenaValve Technology | This is the first major RCT of TAVR vs. SAVR for aortic regurgitation — a new frontier. The ESC 2025 guidelines rate TAVI for AR as Class IIb; positive results here could reshape the landscape. Updated: April 13, 2026.
STAR Trial (Siegel TAVR) (NCT07278310) — Status: RECRUITING | Enrollment: 1,025 | Sponsor: MiRus | Next-generation TAVR device pivotal study. Updated: April 9, 2026.
DurAVR® THV Pivotal Trial (NCT07194265) — Status: RECRUITING | Enrollment: 1,650 | Sponsor: Anteris Technologies | Comparing DurAVR to SAPIEN and Evolut series — the largest TAVR device comparison trial currently enrolling. Updated: April 8, 2026.
DurAVR™ THV Early Feasibility Study (NCT05712161) — Status: ACTIVE, NOT RECRUITING | Enrollment: 15 | Sponsor: Anteris Technologies | Updated: April 8, 2026.
Navitor TAVI Global Investigation (NCT04788888) — Status: ACTIVE, NOT RECRUITING | Enrollment: 434 | Sponsor: Abbott | Updated: April 13, 2026.
Hydra THV vs. BEV for Valve-in-Valve TAVI (NCT07524595) — Status: NOT YET RECRUITING | Enrollment: 111 | Sponsor: NUI Galway | Addresses the growing valve-in-valve population. Updated: April 13, 2026.
Abbott First-in-Human Balloon-Expandable TAVI (NCT07082426) — Status: ACTIVE, NOT RECRUITING | Enrollment: 8 | Sponsor: Abbott | Abbott's entry into balloon-expandable TAVR. Updated: April 8, 2026.
PERFECT (Evolut FX+ Registry, Portugal) (NCT07343674) — Status: RECRUITING | Enrollment: 500 | Sponsor: Portuguese Association of Interventional Cardiology | Updated: April 8, 2026.
TRACS Trial (TAVI With or Without On-Site Cardiac Surgery) (NCT05751577) — Status: ACTIVE, NOT RECRUITING | Enrollment: 657 | Sponsor: Azienda USL di Bologna | Important for the debate about TAVI site-of-care requirements. Updated: April 8, 2026.
Remote ECG Monitoring Post-TAVI (NCT07521800) — Status: RECRUITING | Enrollment: 250 | Sponsor: Medical University of Silesia | Updated: April 13, 2026.
Pharmacological Prevention of New-Onset AF After TAVR (NCT07519161) — Status: NOT YET RECRUITING | Enrollment: 198 | Sponsor: Shanghai East Hospital | Comparing metoprolol vs. amiodarone. Updated: April 9, 2026.

Mitral Valve Repair Trials

[LANDMARK] REPAIR-MR (MitraClip vs. Surgery for Primary MR) (NCT04198870) — Status: ACTIVE, NOT RECRUITING | Enrollment: 500 | Sponsor: Abbott | This is one of the most anticipated trials in structural heart disease. It directly addresses whether TEER can match surgical repair for primary MR — currently, both guidelines position TEER as subordinate to surgery (Class IIa) for PMR. Results will be pivotal. 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. GDMT for secondary MR — will extend the COAPT evidence base. Last updated: March 3, 2026.
[LANDMARK] CLASP IID/IIF (PASCAL vs. MitraClip) (NCT03706833) — Status: ACTIVE, NOT RECRUITING | Enrollment: 1,247 | Sponsor: Edwards Lifesciences | Head-to-head PASCAL vs. MitraClip comparison — results will define the competitive landscape in TEER. Updated: April 9, 2026.
Impact of TAVI and Mitral Repair on Sleep-Disordered Breathing (NCT07520656) — Status: RECRUITING | Enrollment: 150 | Updated: April 9, 2026.

Mitral Valve Replacement Trials

[LANDMARK] Intrepid TMVR Pivotal (NCT03242642) — Status: RECRUITING | Enrollment: 1,056 | Sponsor: Medtronic Cardiovascular | The largest TMVR trial underway. Results will determine whether transcatheter mitral replacement can offer a viable alternative to surgical repair/replacement in high-risk patients. Updated: March 31, 2026.
Edwards EVOQUE Eos MISCEND Study (Mitral Replacement) (NCT02718001) — Status: ACTIVE, NOT RECRUITING | Enrollment: 123 | Sponsor: Edwards Lifesciences | Updated: April 13, 2026.

Tricuspid Valve Repair Trials

[LANDMARK] TRILUMINATE Pivotal (TriClip for TR) (NCT03904147) — Status: ACTIVE, NOT RECRUITING | Enrollment: 572 | Sponsor: Abbott | The foundational trial for transcatheter tricuspid repair. Two-year data supported the ESC 2025 Class IIa recommendation. Long-term follow-up continues. Last updated: December 19, 2024.
[LANDMARK] CLASP II TR (PASCAL for TR) (NCT04097145) — Status: RECRUITING | Enrollment: 870 | Sponsor: Edwards Lifesciences | PASCAL system for tricuspid repair vs. medical therapy. Updated: April 6, 2026.

Tricuspid Valve Replacement Trials

[LANDMARK] TRISCEND II (EVOQUE Tricuspid Replacement) (NCT04482062) — Status: ACTIVE, NOT RECRUITING | Enrollment: 864 | Sponsor: Edwards Lifesciences | The pivotal trial behind today's JAMA registry publication. The real-world STS/ACC TVT data now validate these RCT findings at scale. Updated: February 27, 2026.
TRIVITA Pivotal (VDyne TTVR) (NCT07516444) — Status: NOT YET RECRUITING | Enrollment: 730 | Sponsor: VDyne, Inc. | Notable: this trial will directly compare VDyne's TTVR system against the Edwards EVOQUE — the first head-to-head TTVR comparison trial. This represents real competitive entry into Edwards' newly established TTVR franchise. Updated: April 8, 2026.

Other Relevant Trials

Abbott Structural Heart Device Registry (NCT06590467) — Status: RECRUITING | Enrollment: 2,500 | Sponsor: Abbott | Broad device registry including Amplatzer and Epic surgical valves. Updated: April 13, 2026.

Social & Conference Highlights

The JAMA EVOQUE registry publication is dominating structural heart social media today. MedPage Today and Newswise both ran prominent stories highlighting the real-world findings, with MedPage's headline — "Real-World Practice Getting a Handle on Evoque TTVR" — capturing the learning-curve narrative. The Cardiovascular Business roundup links the TTVR data with FDA's AI cardiac amyloidosis clearance and paravalvular leak considerations after TTVR, reflecting the expanding complexity of the tricuspid space. An archived CMS MEDCAC meeting on TAVR (originally from 2018) resurfaced in news feeds — a reminder that coverage decisions lag behind technology, and that the next national coverage determination review for TAVR could incorporate the younger-patient concerns raised by Glance et al.

Looking ahead: A massive week for structural heart earnings. Abbott reports Wednesday (April 16), followed by Edwards and Boston Scientific on April 22. Watch for commercial TTVR uptake numbers from Edwards, TriClip/MitraClip trajectory from Abbott, and any forward guidance changes reflecting the 2025 ESC guideline expansions. We'll be here to digest it all.

— E. Nolan Beckett, The Valve Wire