Executive Summary
Edwards Lifesciences delivered a blockbuster Q1 2026 — beating EPS estimates by $0.05, posting 12.7% sales growth to $1.65 billion, and raising full-year guidance — sending analyst price targets upward across Wall Street. Meanwhile, a new meta-analysis of eight randomized trials found that cerebral embolic protection devices during TAVR still show no significant reduction in stroke, and a Circulation: Cardiovascular Interventions study demonstrated starkly inferior durability of bioprosthetic versus mechanical valves in pediatric patients. The cardiology world also mourns Eugene Braunwald, the founding father of modern cardiology, who passed away at 96.
Today's digest is dominated by the Edwards earnings story and what it signals about the structural heart market trajectory — but the clinical literature offers important counterweights. The CEPD meta-analysis adds to a growing body of evidence questioning the value proposition of these devices despite widespread adoption, while the pediatric valve durability data from Circulation: Cardiovascular Interventions reinforces a point too often lost in the TAVR enthusiasm: bioprosthetic valves have a shelf life, and for young patients, that remains a serious problem. A single-center report on the Myval THV in bicuspid anatomy adds another small dataset to the BAV-TAVR question, and a provocative WSJ piece highlights the tradeoffs inherent in TAVR's rapid expansion. On the mitral side, a single-center study flags an underappreciated risk — acute hypoxemic respiratory failure post-TEER in patients with concomitant aortic stenosis.
Today's Key Findings
- [NOTABLE] Cerebral embolic protection devices show no stroke reduction after TAVR — meta-analysis of 8 RCTs (11,589 patients) in Clinical Cardiology finds no significant benefit for overall, disabling, or non-disabling stroke. Trial sequential analysis suggests current evidence remains insufficient to definitively rule out benefit.
- [NOTABLE] Bioprosthetic valves show dramatically worse durability than mechanical prostheses in pediatric AVR — Circulation: Cardiovascular Interventions reports freedom from reintervention of only 29% at 10 years for bioprosthetic valves vs. 82% for mechanical valves (HR 4.66, P<0.001).
- Edwards Lifesciences Q1 2026: Revenue $1.65B (+12.7%), adjusted EPS $0.78 vs. $0.73 estimate. Full-year guidance raised. TAVR and TMTT both cited as growth drivers. Multiple analyst upgrades followed.
- Myval THV in bicuspid aortic valve anatomy: Single-center series (n=52) shows comparable 1-year VARC-3 outcomes to trileaflet patients, though pacemaker rates were high (34%).
- Concomitant mild-to-moderate AS independently predicts acute respiratory failure post-TEER (adjusted OR 4.38), highlighting an underappreciated procedural risk in the growing M-TEER population.
Aortic Valve (TAVR/TAVI)
Cerebral Embolic Protection Devices: Still No Proven Stroke Benefit
Gbreel et al. published a meta-analysis of eight RCTs encompassing 11,589 patients in Clinical Cardiology, evaluating cerebral embolic protection devices (CEPDs) during TAVI. The results are sobering for CEPD advocates: no significant difference in overall stroke (RR 0.92, 95% CI 0.75–1.14), no difference in disabling or non-disabling stroke, and no mortality benefit. A transient improvement in cognitive testing (MoCA scores) at 2–5 days disappeared at later follow-up. The Sentinel device showed a non-significant trend toward reduced disabling stroke, but the trial sequential analysis explicitly states that current evidence is insufficient to definitively confirm or refute CEPD efficacy. This is an important finding given the growing adoption of CEPDs in clinical practice — often driven by face validity rather than hard outcomes data. Operators and programs should carefully weigh the added cost and procedural complexity against this evidence gap.
Bioprosthetic vs. Mechanical Valves in Pediatric AVR: A Stark Durability Gap
[NOTABLE] Yokota et al. in Circulation: Cardiovascular Interventions report on 180 pediatric AVR procedures (median age 14.3 years) performed between 2002 and 2024. The results are striking: freedom from reintervention at 10 years was just 29% for bioprosthetic valves versus 82% for mechanical valves (P<0.001). On propensity-adjusted analysis, bioprosthetic valves carried a hazard ratio of 4.66 for reintervention. Younger age at implantation (<12 years) further compounded the problem (HR 3.26). While this is a pediatric population with accelerated structural valve deterioration due to calcium metabolism and growth, the implications extend to the broader TAVR durability debate. If bioprosthetic valves fail this dramatically in young patients, the question of what happens to TAVR valves in patients aged 50–70 over 15–20 years remains unanswered — a gap both the 2020 ACC/AHA and 2025 ESC guidelines acknowledge. This study reinforces why both guidelines recommend SAVR over TAVR in younger patients, and why the ESC sets the SAVR-preferred threshold at age 70 (ACC/AHA at 65).
Myval THV in Bicuspid Aortic Valve: Encouraging but Limited
Magyari et al. report a single-center retrospective series of 52 consecutive BAV patients treated with the Myval balloon-expandable THV, published in Catheterization and Cardiovascular Interventions. At 1 year, there were no significant differences in all-cause mortality (3.9% vs. 10.2%, P=0.185) or stroke (3.9% vs. 2.8%) compared with trileaflet patients. Technical and device success exceeded 95%, with no moderate or severe paravalvular regurgitation in BAV patients. However, several caveats apply: this is a single-center, non-randomized series with modest sample size. The pacemaker rate was notably high at 34% — a concern whether this reflects annular anatomy or device design. Both the 2020 ACC/AHA (Class IIb) and 2025 ESC (Class IIb) guidelines rate TAVI for BAV as having limited evidence. BAV patients were excluded from virtually all major TAVI RCTs, and NOTION 2 showed a numerically higher event rate with TAVI in the BAV subgroup. This study adds modestly to the BAV-TAVR evidence base but does not change the fundamental picture: BAV remains primarily surgical territory, especially in younger patients with favorable operative risk.
Conduction Disturbances After TAVR: Two Instructive Cases
Kesriklioglu et al. in JACC: Case Reports present a compelling case of alternating bundle branch block detected only on Holter monitoring after TAVR, in a patient whose resting ECG had initially normalized. The patient presented with syncope 6 days post-TAVR. A companion editorial by Ayhan and Yakut discusses the broader challenge of post-TAVR conduction management. These cases underscore that a normal post-procedural ECG does not exclude advanced conduction system disease — a clinically relevant point given that new permanent pacemaker implantation after TAVR remains 15–25% depending on valve type, and intermittent high-grade block can be fatal if missed. Extended ambulatory monitoring post-TAVR deserves more systematic implementation.
TAVI in Kathmandu: Global Expansion Continues
Adhikari et al. report the initial 19-patient TAVI experience from Shahid Gangalal National Heart Centre in Nepal, with a 100% procedural success rate and no in-hospital mortality. While these are small numbers, they represent the continued global democratization of TAVI — a trend worth following as emerging economies increasingly adopt transcatheter technologies. The challenge, as always, will be sustaining outcomes as case volumes build and patient selection potentially broadens.
TAVR Nursing Education Review
Kinsaul et al. in the American Journal of Nursing describe TAVR as having evolved "from novel to normal" and argue that it is now "the preferred, first-line treatment for patients with AS." Editorial note: This framing overstates the evidence. While TAVR is indeed first-line for patients over 80 or with elevated surgical risk, both the ACC/AHA and ESC guidelines continue to recommend SAVR as the preferred approach for younger, lower-risk patients — below age 65 (ACC/AHA) or 70 (ESC). Characterizing TAVR as universally preferred risks contributing to the indication creep that Badhwar and others have warned about.
Mitral Valve (MitraClip, PASCAL, TMVR)
Concomitant AS Predicts Respiratory Failure After M-TEER
Sonbol et al. in Catheterization and Cardiovascular Interventions report a single-center retrospective study of 238 M-TEER patients, finding that concomitant mild-to-moderate AS was independently associated with acute hypoxemic respiratory failure within 24 hours (16.7% vs. 3.8%, adjusted OR 4.38, 95% CI 1.36–14.61). Importantly, there were no differences in 30-day readmission, heart failure hospitalization, AKI, or in-hospital mortality. The mechanism likely involves acute afterload increase as MR reduction unmasks fixed AS physiology. The authors appropriately flag this as hypothesis-generating given the single-center design and small number of events (n=30 in the AS group). Nevertheless, this has practical implications for procedural planning: patients with coexistent AS undergoing TEER may benefit from closer hemodynamic monitoring and lower thresholds for post-procedural respiratory support. It also raises the question of whether concurrent AS should factor more prominently into M-TEER patient selection — particularly as the ESC 2025 guidelines have elevated TEER for secondary MR to Class I.
MitraClip in Local TV Coverage
KXII reports on a local patient's MitraClip treatment, reflecting the continued mainstreaming of M-TEER in community awareness.
Surgical vs. Transcatheter Comparisons
WSJ: "A Breakthrough Heart Procedure Comes With Risky Tradeoffs"
The Wall Street Journal published a feature on the tradeoffs of TAVR's rapid expansion — a piece that aligns with concerns raised in the structural heart surgery literature by Badhwar, Kaul, and others. While the article's full content is behind a paywall, the timing is notable: it arrives on the same day Edwards reports record TAVR growth and raises guidance. The tension between commercial momentum and clinical caution is the central narrative of structural heart disease in 2026. The 2025 ESC guidelines expanded TAVI indications to patients ≥70 with tricuspid aortic valves and suitable anatomy, but for every patient who benefits from broader access, there remains the question of whether patients who would do better with SAVR are being steered toward the catheter lab. Long-term durability data beyond 10 years remain conspicuously absent.
Imaging Review: Foundation of Modern Valve Therapy
Peer et al. in Therapeutische Umschau provide a comprehensive review of multimodality imaging across the valve therapy spectrum — from TTE for initial diagnosis to cardiac CT for TAVI planning and TEE for intraprocedural guidance. The review emphasizes that imaging is the "foundation of modern, increasingly catheter-based valve therapy" and notes CT's expanding role in tricuspid and mitral transcatheter planning.
Device & Technology
PFO and Migraine: Metabolomic Insights
Luo et al. in iScience present exploratory metabolomic profiling in migraine patients with PFO (n=30 patients, n=17 controls), identifying the gut microbiota-derived metabolite indoleacrylic acid (IA) as inversely associated with migraine severity. In an independent validation cohort (n=220), IA combined with hs-CRP improved discrimination for PFO-associated migraine (AUC 0.722). While this is early-stage, hypothesis-generating work, it contributes to the growing mechanistic understanding of the PFO-migraine connection — potentially relevant for patient selection in PFO closure decisions.
Hybrid Valve-in-Valve in Failing Fontan Physiology
Sumal et al. in the Journal of Cardiothoracic and Vascular Anesthesia describe the anesthetic management of a hybrid valve-in-valve procedure in a child with failing Fontan physiology and plastic bronchitis — a case highlighting the increasing complexity of structural reintervention in congenital heart disease.
Industry & Market
Edwards Lifesciences Q1 2026: A Beat Across the Board
[NOTABLE] Edwards Lifesciences reported Q1 2026 revenue of $1.65 billion, up 12.7% year-over-year, beating consensus estimates. Adjusted EPS came in at $0.78 versus the $0.73 estimate — a $0.05 beat. Both TAVR and the Transcatheter Mitral and Tricuspid Therapies (TMTT) segment were cited as growth drivers. Management raised full-year 2026 sales and adjusted EPS guidance, and announced a $500 million accelerated share buyback program. The earnings call highlighted continued TAVR volume growth, share gains, and early TMTT commercialization progress.
Analyst Reactions: Broad Upgrades to Price Targets
The post-earnings analyst response was uniformly positive:
- Barclays: PT raised to $110 from $104, maintains Overweight
- Goldman Sachs: PT raised to $98 from $97, maintains Buy
- Truist: PT raised on TAVR growth outlook
- Evercore ISI: PT raised to $93 from $92, maintains Outperform
- BTIG: PT raised on strong Q1 beat
- Canaccord: Cut PT on valuation concerns — the lone contrarian voice
Google Search Trends Reflect Shift Toward Minimally Invasive Heart Care
News-Medical reports that Google search data reflects growing public interest in minimally invasive cardiac procedures, consistent with the broader market trends driving TAVR and TEER adoption.
In Memoriam: Eugene Braunwald (1929–2026)
TCTMD reports that Eugene Braunwald, widely regarded as the father of modern cardiology, has died at age 96. Braunwald's contributions span the entire arc of contemporary cardiovascular medicine — from his foundational work on heart failure pathophysiology and the TIMI trials to his transformative role in medical education through Braunwald's Heart Disease. His influence on valvular heart disease is profound: his early work on the hemodynamics of mitral regurgitation and aortic stenosis laid the groundwork for the interventional era we now cover daily. The field has lost an irreplaceable giant.
Financial Analysis
Edwards Lifesciences' Q1 2026 earnings report is the dominant financial story in structural heart today, and the numbers tell a clear story of continued market expansion. Revenue of $1.65 billion represents 12.7% year-over-year growth, with both TAVR and TMTT (transcatheter mitral and tricuspid therapies) contributing meaningfully. The $0.05 EPS beat ($0.78 vs. $0.73 consensus) and raised full-year guidance signal management confidence in sustained demand. The $500 million accelerated share buyback program reflects strong free cash flow generation and a capital allocation strategy focused on returning value to shareholders while continuing to invest in pipeline development.
The analyst consensus response was largely positive, with price target increases from Barclays ($110), Goldman Sachs ($98), Truist, Evercore ISI ($93), and BTIG. Canaccord was the contrarian, cutting its target on valuation concerns — a reasonable position given EW's trailing P/E of 44x, which prices in considerable future growth. The stock's 2.2% decline on the day despite the earnings beat suggests some "buy the rumor, sell the news" dynamics, with the shares having run up in anticipation.
Looking across the structural heart industry, Edwards' strength contrasts with broader medtech headwinds. Medtronic (MDT) is down 9.2% over six months, reflecting diversified medtech challenges beyond its structural heart portfolio. Abbott (ABT) has been hit harder, down 26.3% over six months — largely driven by litigation and tariff exposure rather than structural heart-specific factors. Boston Scientific (BSX), despite a "strong buy" consensus, is off 35% over six months amid broader market volatility. The divergence between Edwards' focused structural heart growth story and the struggles of diversified medtech peers highlights the premium the market places on pure-play exposure to high-growth transcatheter procedures.
Critically, investors should weigh Edwards' growth narrative against the clinical evidence landscape. The ESC 2025 guidelines' expansion of TAVI indications to patients ≥70 and TEER for secondary MR to Class I represent meaningful total addressable market expansion in Europe. However, the ACC/AHA guidelines have not yet followed on several key points, and the next U.S. guideline update could either validate or temper the European expansion. The TMTT segment remains in early commercialization, with TRILUMINATE, CLASP II TR, and TRISCEND II providing the evidence base for tricuspid therapies, and COAPT/RESHAPE-HF2 underpinning the mitral story. Long-term durability uncertainty for TAVR in younger patients — highlighted today by the pediatric AVR durability data — represents the most significant risk to the bull thesis on continued TAVR age expansion.
Valve Industry Stocks
Edwards Lifesciences (EW)
- Close: $79.72 | Daily Change: -$1.81 (-2.22%)
- 6-Month Performance: +$3.62 (+4.76%)
- Market Cap: $46.0B | P/E (trailing): 44.04 | P/E (forward): 23.8 | Beta: 0.94
- 52-Week Range: $72.30 – $87.89
- Analyst Consensus: Buy | Target: $96.33 (range $84–$110, 27 analysts)
- Next Earnings: July 23, 2026 (EPS est: $0.73 | Rev est: $1.60B)
The headline story in structural heart today. Despite beating Q1 estimates and raising guidance, shares fell 2.2% — potentially reflecting profit-taking after a pre-earnings run-up or concern about the 44x trailing P/E multiple. Multiple analyst price target increases (Barclays to $110, Goldman to $98, Evercore ISI to $93) reflect confidence in the TAVR growth trajectory and TMTT pipeline. Canaccord's target cut on valuation grounds is the outlier but worth noting. The $500M buyback signals management's conviction. Key to the investment thesis: whether TAVR age expansion per ESC 2025 guidelines translates into sustained volume growth, and whether TMTT can scale commercially.
Medtronic (MDT)
- Close: $83.79 | Daily Change: +$0.57 (+0.68%)
- 6-Month Performance: -$8.44 (-9.15%)
- Market Cap: $107.6B | P/E (trailing): 23.41 | P/E (forward): 13.83 | Beta: 0.76
- 52-Week Range: $79.93 – $106.33
- Analyst Consensus: Buy | Target: $109.08 (range $91–$121, 25 analysts)
- Next Earnings: June 3, 2026 (EPS est: $1.56 | Rev est: $9.62B)
Medtronic continues to trade near its 52-week low, with the stock down 9.2% over six months. The structural heart portfolio (Evolut TAVR, Intrepid TMVR) is a growth area within a diversified conglomerate facing headwinds in other segments. The Intrepid TMVR pivotal trial (NCT03242642) continues recruiting, and the Evolut Low Risk long-term follow-up data will be critical for the SAVR-vs-TAVR narrative. The forward P/E of 13.83 looks attractive relative to Edwards' 23.8, but reflects the market's lower growth expectations for the diversified model.
Abbott (ABT)
- Close: $92.48 | Daily Change: +$0.78 (+0.85%)
- 6-Month Performance: -$32.94 (-26.27%)
- Market Cap: $160.7B | P/E (trailing): 25.9 | P/E (forward): 15.25 | Beta: 0.78
- 52-Week Range: $90.72 – $139.06
- Analyst Consensus: Buy | Target: $118.64 (range $92–$143, 25 analysts)
- Next Earnings: July 16, 2026 (EPS est: $1.28 | Rev est: $12.54B)
Abbott's steep 26% six-month decline reflects headwinds extending well beyond its structural heart business (MitraClip/TriClip). The stock is trading near its 52-week low at $92.48, with the current price essentially at the bottom of the analyst target range. For structural heart watchers, TRILUMINATE Pivotal long-term data and the REPAIR-MR trial (MitraClip vs. surgery for primary MR) remain the key catalysts. The MitraClip G5 registry (NCT07543874) is about to begin recruiting, which will generate important real-world data on the next-generation device.
Boston Scientific (BSX)
- Close: $65.69 | Daily Change: +$0.82 (+1.26%)
- 6-Month Performance: -$35.42 (-35.03%)
- Market Cap: $97.6B | P/E (trailing): 27.49 | P/E (forward): 17.32 | Beta: 0.78
- 52-Week Range: $59.39 – $109.50
- Analyst Consensus: Strong Buy | Target: $87.06 (range $69–$110, 31 analysts)
- Next Earnings: July 22, 2026 (EPS est: $0.83 | Rev est: $5.39B)
Despite maintaining a "strong buy" consensus from 31 analysts, BSX has been the worst performer in the group, down 35% over six months. The ACURATE neo2 TAVR system and WATCHMAN left atrial appendage closure device are key structural heart assets. The stock's dramatic decline from its 52-week high of $109.50 to $65.69 represents a significant de-rating, with the current price well below even the bottom of the analyst target range ($69).
Anteris Technologies (AVR.AX)
- Close: A$7.60 | Daily Change: +A$0.04 (+0.53%)
- 6-Month Performance: -A$1.20 (-13.64%)
- Market Cap: A$0.7B | P/E (forward): -3.49 | Beta: 0.55
- 52-Week Range: A$4.68 – A$9.79
- Analyst Target: A$13.00 (1 analyst)
Anteris remains a clinical-stage company with its DurAVR THV system currently recruiting in the pivotal trial (NCT07194265, enrollment target 1,650). The negative forward P/E reflects pre-revenue status. The stock has been volatile, trading in a wide range between A$4.68 and A$9.79 over the past year. The DurAVR trial is randomizing against SAPIEN and Evolut THV series — a direct head-to-head that will be pivotal for the company's future.
Note: JenaValve Technology, J Valve Technology, and Meril Life Sciences are private companies with no public stock data available.
Market Outlook: Edwards' Q1 beat crystallizes the structural heart investment thesis: TAVR volumes continue growing, TMTT is transitioning from R&D cost center to revenue contributor, and guideline expansions (particularly ESC 2025) are enlarging the addressable market. However, the broader medtech selloff affecting MDT, ABT, and BSX — driven by tariff concerns, litigation, and macroeconomic uncertainty — reminds us that even the best clinical stories operate within a challenging market environment. The growing divergence between Edwards' focused structural heart growth and the struggles of diversified peers may ultimately pressure those companies to spin off or further invest in their structural heart divisions.
Clinical Trial Updates
Aortic Valve Trials
- NCT07539909 — Alternative Peripheral TAVI Accesses
- Status: Not yet recruiting | Enrollment: 600
- Sponsor: Medical University of Silesia
- Observational study of non-transfemoral TAVI access routes. Relevant as transfemoral access is a prerequisite for TAVI-preferred pathways in both ACC/AHA and ESC guidelines.
- NCT04443023 — Comparison of Eligible TAVI-valves – Cohort B
- Status: Completed | Enrollment: 1,031
- Sponsor: Aarhus University Hospital Skejby
- Head-to-head comparison of TAVI valve systems. Results anticipated.
- NCT05145283 — Conestat Alfa for Cerebral/Renal Protection During TAVI
- Status: Completed | Phase: 2 | Enrollment: 141
- Sponsor: University Hospital Basel
- Phase 2 study of complement inhibitor for organ protection during TAVI — relevant given today's CEPD meta-analysis showing no stroke benefit with mechanical protection.
- NCT07545369 — ULTRA-EVOLUT RCT: SAPIEN 3 Ultra Resilia vs. Evolut FX
- Status: Not yet recruiting | Enrollment: 200
- Sponsor: Assiut University
- Head-to-head RCT of latest-generation balloon-expandable vs. self-expanding valves.
- NCT06638268 — TAVI in Cardiogenic Shock (TACTICS)
- Status: Recruiting | Enrollment: 30
- Sponsor: Rigshospitalet, Denmark
- Comparing acute vs. stabilized subacute TAVI in cardiogenic shock — a frontier population.
- NCT07194265 — DurAVR® THV Pivotal Trial (Anteris Technologies)
- Status: Recruiting | Enrollment: 1,650
- Sponsor: Anteris Technologies
- Pivotal trial randomizing the DurAVR single-piece TAVR valve against SAPIEN and Evolut. A potential disruptor if the durability advantages of the ADAPT tissue treatment are confirmed.
- NCT07317804 — ECHO-TAVR: Echo-Guided vs. Fluoroscopy-Guided TAVR
- Status: Not yet recruiting | Phase: 4 | Enrollment: 212
- Sponsor: China National Center for Cardiovascular Diseases
- Evaluating whether echocardiographic guidance can replace or complement fluoroscopy for TAVR deployment.
- NCT06857201 — RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR
- Status: WITHDRAWN | Enrollment: 0
- Sponsor: London Health Sciences Centre
- This trial comparing left bundle branch area pacing to right ventricular pacing post-TAVR has been withdrawn before enrolling — a loss given the clinical importance of optimizing pacing strategy in post-TAVR patients who require pacemakers.
- [LANDMARK] NCT02701283 — Evolut Low Risk (Long-term Follow-up)
- Status: Active, not recruiting | Enrollment: 2,223
- Sponsor: Medtronic Cardiovascular
- Long-term follow-up of the landmark Evolut Low Risk trial continues. These data are essential for the SAVR-vs-TAVR debate, particularly in determining whether the ESC 2025 threshold of age 70 for TAVI preference is supported by long-term outcomes. Updated April 2026.
Mitral Repair Trials
- NCT07543874 — MitraClip Generation 5 Registry
- Status: Not yet recruiting | Enrollment: 1,000
- Sponsor: University Hospital of Cologne
- Real-world registry for the next-generation MitraClip G5 system. Will provide important data on iterative device improvements in clinical practice.
- [LANDMARK] NCT04198870 — REPAIR-MR (MitraClip vs. Surgery for Primary MR)
- Status: Active, not recruiting | Enrollment: 500
- Sponsor: Abbott Medical Devices
- This landmark trial comparing TEER to surgical mitral valve repair in primary MR is one of the most anticipated readouts in structural heart. Both ACC/AHA and ESC guidelines currently favor surgery for primary MR; REPAIR-MR could reshape the landscape.
- [LANDMARK] NCT05051033 — PRIMATY (MitraClip vs. Medical Therapy for Secondary MR)
- Status: Recruiting | Enrollment: 450
- Sponsor: Annetine Gelijns
- Compares TEER to mitral valve repair surgery for secondary MR — critical for defining the role of surgical approaches in the post-COAPT era. Updated March 2026.
- [LANDMARK] NCT03706833 — COAPT (Long-term Follow-up)
- Status: Active, not recruiting | Enrollment: 1,247
- Sponsor: Edwards Lifesciences (now includes PASCAL system)
- Continued follow-up of the trial that defined TEER for secondary MR. The 5-year data drove the ESC 2025 upgrade to Class I. Longer follow-up will clarify durability of benefit. Updated April 2026.
- NCT02924363 — MITRA-REVERSE (CMR Assessment of Remodeling After MitraClip)
- Status: Completed | Enrollment: 54
- Sponsor: Dipan Shah
- CMR-based study of cardiac remodeling post-MitraClip. Results pending publication.
Mitral Replacement Trials
- [LANDMARK] NCT03242642 — Intrepid TMVR Pivotal (Medtronic)
- Status: Recruiting | Enrollment: 1,056
- Sponsor: Medtronic Cardiovascular
- The largest pivotal TMVR trial, comparing the Intrepid system to conventional therapy. Updated March 2026. TMVR remains a challenging frontier — if successful, this could open a major new device market.
Tricuspid Repair Trials
- [LANDMARK] NCT03904147 — TRILUMINATE Pivotal (TriClip for TR)
- Status: Active, not recruiting | Enrollment: 572
- Sponsor: Abbott Medical Devices
- The landmark trial that drove ESC 2025's Class IIa recommendation for transcatheter TR therapy. Long-term follow-up continues.
- [LANDMARK] NCT04097145 — CLASP II TR (PASCAL for TR)
- Status: Recruiting | Enrollment: 870
- Sponsor: Edwards Lifesciences
- Pivotal trial of the PASCAL system for TR, competing with TriClip in the TEER-for-TR space. Updated April 2026.
- NCT06479824 — TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)
- Status: Suspended | Enrollment: 60
- Sponsor: NHLBI / Cook
- Novel approach to transcatheter tricuspid annuloplasty via pericardial access. Suspension noted — worth monitoring for updates.
Tricuspid Replacement Trials
- [LANDMARK] NCT04482062 — TRISCEND II (Evoque Tricuspid Replacement)
- Status: Active, not recruiting | Enrollment: 864
- Sponsor: Edwards Lifesciences
- Key trial of transcatheter tricuspid valve replacement. TRISCEND II data helped support the ESC 2025 Class IIa recommendation. Updated February 2026.
- NCT07536724 — TRICENTO G2 First-in-Man (Medira)
- Status: Not yet recruiting | Enrollment: 10
- Sponsor: Medira GmbH
- First-in-human trial of a new transcatheter tricuspid valve system — the TTVR space continues to attract new entrants.
Other Valve-Related Trials
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction
- Status: Not yet recruiting | Enrollment: 1,000
- Sponsor: NHLBI
- Advanced CT reconstruction techniques — relevant for TAVI/TMVR planning.
- NCT06412354 — EasyCross™ Self-Centering Catheter
- Status: Completed | Enrollment: 20
- Sponsor: Vivheart s.r.l.
- First-in-human study of a self-centering catheter for valve crossing — a niche but practically relevant device.
- NCT07511673 — Preoperative Dental Screening Before Valve Surgery/TAVI
- Status: Not yet recruiting | Enrollment: 1,300
- Sponsor: Region Skane
- RCT evaluating whether preoperative dental screening reduces endocarditis and complications after valve intervention — an important and underexplored question.
- NCT03152773 — MRI-Guided Heart Catheterization
- Status: Suspended | Enrollment: 22
- Sponsor: NHLBI
- MRI fluoroscopy for catheterization — futuristic but currently paused.
Social & Conference Highlights
No major conference proceedings today. The structural heart community's attention is split between processing the Edwards earnings beat and mourning Eugene Braunwald. Expect significant tributes across all major cardiology platforms in the coming days.
Looking Ahead: Tomorrow, watch for continued analyst reaction to Edwards' Q1 results and any early readout signals from ongoing trials. The Evolut Low Risk long-term data and REPAIR-MR results remain the two most consequential pending readouts for the field. Today's pediatric AVR durability study from Circulation: Cardiovascular Interventions and the CEPD meta-analysis both deserve closer attention than they'll likely receive amid the Edwards earnings noise — they speak to questions about bioprosthetic valve limitations and procedural adjuncts that will define the next decade of structural heart practice.
— E. Nolan Beckett, The Valve Wire