Executive Summary
Today's biggest story comes from JACC: the ALERT trial — a landmark cluster-randomized trial across 35 U.S. hospitals — demonstrates that simple automated electronic alerts in the medical record significantly increase timely valve evaluation and intervention for patients with severe aortic stenosis and mitral regurgitation, addressing one of the most persistent problems in valve care: undertreatment. Meanwhile, Canadian registry data show transcatheter tricuspid valve replacement with the Evoque system cuts heart failure hospitalizations by 76%, and a new meta-analysis finds self-expanding TAVR valves outperform balloon-expandable platforms on hemodynamics in patients with small aortic annuli — though clinical outcomes remain comparable. Edwards Lifesciences reported Q1 earnings and saw its stock rise nearly 3%, with Barclays lifting its price target.
For the clinical audience: the ALERT trial (JACC) is exactly the kind of systems-level innovation that valve specialists should care about — because even the best devices are useless if patients never reach a Heart Team. The 27% relative improvement in the win-ratio composite, with consistent effects across sex, race, socioeconomic status, and geography, makes this one of the most immediately actionable findings in recent valve literature. On the tricuspid front, the Canadian Evoque registry adds real-world texture to TRISCEND II data, though the compassionate-use design and modest sample (n=75) demand the usual caution. And in the TAVR space, a practical CT-based vascular risk model for transfemoral access and a thoughtful case report on valve-in-homograft planning both address real-world procedural challenges that don't always make headlines but shape daily practice.
Today's Key Findings
- [NOTABLE] ALERT Trial (JACC): Automated EHR alerts for significant AS and MR improved guideline-directed evaluation (win ratio 1.27, P=0.007) across 5 health systems and 35 hospitals, with higher rates of valve intervention (13.4% vs 9.6%) and Heart Team evaluation (22.7% vs 17.9%). No heterogeneity by age, sex, race, or rurality. A scalable, low-cost strategy to close the undertreatment gap.
- Canadian Evoque TTVR Registry: In 75 high-risk patients, TTVR reduced heart failure hospitalizations by 76% at one year (P<0.001), with 94.3% achieving ≤mild TR and 6.7% one-year mortality. Compassionate-use and trial patients showed comparable benefit.
- BEV vs SEV in Small Annulus TAVR (Meta-Analysis): Self-expanding valves demonstrated superior hemodynamics (lower gradients, larger effective orifice area, less PPM) but higher pacemaker and bleeding rates. No difference in mortality or stroke.
- CT-Guided Vascular Risk Stratification for TF-TAVI: A "fragile access" profile — female sex, sheath-to-artery ratio >1, and diffuse circumferential calcification — identified the ~13% of patients experiencing vascular events, enabling selective use of femoral protection strategies.
- AI-Based RV Work Analysis for Tricuspid Interventions: A novel pressure-strain-volume metric (PSV-GWW) independently predicted TR progression after repair and the composite of HF hospitalization/death after any TTVI.
Aortic Valve (TAVR/TAVI)
CT-Guided Vascular Risk Stratification: Toward Selective Femoral Protection
Bianchini et al. analyzed 960 consecutive TF-TAVI patients with high-quality preprocedural CT imaging to identify predictors of operative iliofemoral vascular events (American Journal of Cardiology). Vascular events occurred in 13.3% — a reminder that even in the contemporary era, access-site complications remain a meaningful source of morbidity. Events were associated with significantly higher 30-day mortality (4.7% vs 1.3%, P=0.022) and major bleeding. Three independent predictors emerged: female sex (OR 1.90), sheath-to-artery ratio (STAR) >1 (OR 1.63), and circumferential calcification ≥90° across all three iliofemoral segments (OR 2.45). The authors propose a CT-derived "fragile access" profile to selectively deploy femoral protection strategies — a sensible, practical approach to procedural streamlining that avoids the one-size-fits-all extremes of universal protection or universal minimalism. Importantly, this study pre-dates widespread adoption of next-generation low-profile delivery systems, and the 13.3% event rate should be benchmarked against evolving technology.
BEV vs SEV in Small Aortic Annulus: Hemodynamics vs Complications
Daniyal et al. present an updated meta-analysis of 14 studies (2 RCTs, 12 propensity-matched) comparing balloon-expandable and self-expanding TAVR valves in patients with small aortic annuli (American Journal of Cardiology). Self-expanding valves won convincingly on hemodynamics: larger indexed EOA (MD +0.18 cm²/m²), lower mean gradient (MD −4.27 mmHg), and substantially less patient-prosthesis mismatch (RR 0.64 for any PPM; RR 0.38 for severe PPM). However, balloon-expandable valves had lower pacemaker rates (RR 0.64) and less major bleeding (RR 0.69). Neither platform showed superiority for mortality or stroke. The editorial bottom line: small annulus TAVR requires explicit trade-off discussions — hemodynamic optimization with self-expanding platforms vs lower conduction and bleeding risk with balloon-expandable valves. Whether hemodynamic differences translate to long-term clinical outcomes remains genuinely unknown, and prospective studies with contemporary devices (e.g., SAPIEN 3 Ultra Resilia, Evolut FX) are needed. The ongoing Evolut FX vs SAPIEN 3 Ultra Resilia trial (n=1,346) should eventually provide more definitive answers.
Planning TAVR in a Failed Aortic Homograft
Crane and Gallo provide a practical case-based guide to transcatheter valve-in-homograft planning in JACC Case Reports. While no abstract is available, this speaks to an increasingly relevant clinical challenge. Homograft degeneration poses unique anatomical problems for TAVR — irregular geometry, variable calcification patterns, and uncertain coronary access — making meticulous CT planning essential. This dovetails with the broader lifetime management framework emphasized in the ESC 2025 guidelines, which stresses that index procedure planning must account for future reintervention scenarios.
TAVR Adoption in India
The Deccan Chronicle reports on rising TAVR adoption in Hyderabad, reflecting broader expansion of transcatheter valve programs across India. While encouraging for access, it's worth noting that Indian TAVR populations differ significantly from Western trial cohorts — younger age, higher BAV prevalence, more rheumatic disease — and local outcomes registries will be critical to ensure appropriateness and safety in this growing market.
Sex Differences in Post-TAVR Survival
Cardiovascular Business reports that women live longer after TAVR than men — a finding consistent with prior registry and trial data showing that while women face higher periprocedural complication rates (vascular events, as today's CT-guided study also highlights), they may derive greater long-term survival benefit. This paradox likely reflects a combination of smaller body size, different remodeling patterns, and lower comorbidity burden among female TAVR candidates. It underscores the importance of sex-specific risk assessment rather than applying uniform decision-making frameworks.
Mitral Valve (MitraClip, PASCAL, TMVR)
Combined MitraClip and LAA Closure in a Single Sitting
Business Standard reports that Kauvery Hospital in India performed a combined MitraClip and left atrial appendage closure (LAAO) in a single session. This combined approach is clinically rational for patients with atrial functional mitral regurgitation and concomitant atrial fibrillation — exactly the population the ESC 2025 guidelines now formally recognize as "atrial secondary MR." The ESC recommends surgical MV intervention + surgical AF ablation + LAAO (Class IIa) and TEER for inoperable patients (Class IIb). Single-session transcatheter MitraClip + LAAO, while technically feasible, remains off-guideline and should be evaluated in formal registries before broader adoption. Procedural complexity, contrast exposure, and complication risk all increase with combined procedures.
Tricuspid Valve (TriClip, TTVR)
Canadian Evoque Registry: TTVR Dramatically Reduces Heart Failure Hospitalizations
[NOTABLE] Patrascu et al. report one-year outcomes from a prospective, multicenter Canadian registry of 75 high-risk patients (mean STS score 8.2%) undergoing transcatheter tricuspid valve replacement with the Evoque system (Canadian Journal of Cardiology). The headline finding: a 76.1% relative reduction in annualized heart failure hospitalization rates (P<0.001). Technical success was 97.3%, with 94.3% achieving ≤mild TR — consistent with the near-complete TR elimination that differentiates TTVR from TEER. One-year mortality was 6.7%, NYHA III/IV decreased from 76% to 10%, and KCCQ scores improved by +17 points.
Important context and caveats: This is a registry of compassionate-use and trial patients — not randomized, and subject to selection bias, missing data, and the inevitable enthusiasm that accompanies a new therapy. The 75-patient sample limits statistical power for safety signals. Baseline NYHA IV (OR 3.96) and prior HFH (OR 2.31) independently predicted the composite endpoint, suggesting that even in this favorable overall picture, the sickest patients don't do as well — echoing the "too-late referral" problem the ESC 2025 guidelines emphasize for tricuspid disease. The comparison with medical therapy is observational (before-after HFH rates), not randomized. That said, these results are directionally consistent with TRISCEND II pivotal data and the TVT Registry's real-world TTVR experience (98.4% successful implantation, 3.1% 30-day mortality in 1,034 patients). Transcatheter tricuspid valve replacement is now ESC IIa — and data like these are building the case, though longer follow-up and attention to valve durability, thrombosis, and pacemaker requirements remain essential. The ACC/AHA 2020 guidelines don't yet address TTVR; the next update will be telling.
AI-Based RV Work Predicts Outcomes After Tricuspid Intervention
Bartkowiak et al. introduce an AI-driven pressure-strain-volume (PSV) analysis of RV function in 166 patients undergoing transcatheter tricuspid valve intervention (JASE). The key finding: a novel metric — global wasted work (PSV-GWW) — independently predicted TR progression after repair (adjusted OR 1.108 per 100-unit increase, P=0.028) and the composite of HF hospitalization/death (adjusted HR 1.038, P=0.036). Conventional RV parameters did not predict TR progression. This is a multicenter retrospective study with inherent limitations, and the absolute effect sizes are modest. But the conceptual advance is significant: if validated prospectively, PSV-GWW could help identify patients unlikely to benefit from TEER (who might be better served by TTVR) versus those with recoverable RV function. The ESC 2025 guidelines already emphasize avoiding transcatheter tricuspid intervention in patients with "severe RV dysfunction" — better tools to define that threshold are urgently needed.
Surgical vs. Transcatheter Comparisons
No new head-to-head surgical vs. transcatheter comparison studies were published today. However, several findings touch on the interface: the small-annulus TAVR meta-analysis (above) implicitly relates to the surgical alternative, since patients with small annuli may benefit from annular enlargement techniques available only at surgery — a point the ESC 2025 guidelines list as a factor favoring SAVR. Similarly, the ALERT trial's equal benefit for AS and MR patients (win ratio 1.29 and 1.23, respectively) suggests that undertreatment affects both surgical and transcatheter candidates alike, and the barrier is often in the referral pathway, not the operating room or cath lab.
Regulatory & Policy
The 2025 Accra Declaration: Building Cardiac Surgery Capacity in Africa
Yankah et al. publish the 2025 Accra Declaration from the Pan-African Society for Cardiothoracic Surgery (Asian Cardiovascular & Thoracic Annals). This consensus statement from the 1st Pan-African Cardiothoracic Surgery Summit calls for cost-effective cardiac surgical programs, simulation training infrastructure, regional databases, and fellowship programs tailored to Africa's unique disease burden — including rheumatic valve disease, which remains the dominant valvular pathology across the continent. The declaration emphasizes specialized working groups for valve surgery, congenital heart surgery, and CABG. While this isn't a regulatory action per se, it has significant policy implications for global cardiovascular equity. The rush toward transcatheter solutions in high-income countries shouldn't obscure the reality that most of the world still needs better access to basic surgical valve care.
Device & Technology
The AI-based RV pressure-strain-volume analysis described by Bartkowiak et al. (see Tricuspid section above) represents a notable advance in imaging technology for patient selection. Additionally, three Hydra Transcatheter Aortic Valve System registries (Italy, Copenhagen, UK) continue actively enrolling — tracking this emerging Indian-manufactured TAVR platform from Sahajanand Medical Technologies (Meril Life Sciences). With enrollment targets totaling 800 patients across these registries, the Hydra system is positioning for broader European market entry, challenging the Edwards-Medtronic duopoly in TAVR.
Industry & Market
Edwards Lifesciences dominated today's financial headlines, with Barclays lifting its price target following Q1 2026 earnings. The stock rose 2.81% to $83.50, outperforming medtech peers. Institutional activity was mixed: Jennison Associates sold 178,259 shares while Exencial Wealth Advisors trimmed its position — routine portfolio rebalancing rather than directional signals. Edwards' Q1 results appear to have reassured the Street that its TAVR franchise remains on solid ground despite growing competitive pressures from Medtronic's Evolut FX and emerging entrants like Meril's Hydra and Anteris Technologies' DurAVR.
Financial Analysis
The structural heart industry is in an interesting moment. Edwards Lifesciences reported Q1 earnings today and saw an immediate positive market reaction — Barclays raised its price target, and the stock closed at $83.50, up 2.81%. Yet the broader context is more nuanced: Edwards is essentially flat over the last six months (+0.52%), suggesting the market has been cautious about near-term TAVR growth trajectory even as the long-term story (ESC 2025 expanding TAVI indications to ≥70, asymptomatic AS moving to IIa, tricuspid therapies gaining traction) remains compelling. The forward P/E of 24.83 vs trailing 45.14 implies substantial earnings growth is expected, likely driven by the EVOQUE tricuspid program, PASCAL mitral/tricuspid expansion, and continued TAVR volume growth.
The real story in medtech structural heart valuations, however, may be the dramatic underperformance of Abbott (-25.85% over 6 months) and Boston Scientific (-41.57%) — though these are diversified companies where structural heart is only one segment. Abbott's TriClip franchise faces intensifying competition from Edwards' EVOQUE (as today's Canadian registry underscores) and the PASCAL system for tricuspid TEER. Boston Scientific's Millipede transcatheter annuloplasty feasibility study remains stuck at 4 patients enrolled — a reminder that not every device concept survives first contact with clinical reality. Medtronic (-8.83% over 6 months) faces its own headwinds but has upcoming earnings on June 3 that will provide the next read on Evolut FX commercial momentum and the Intrepid TMVR program timeline.
Valve Industry Stocks
Edwards Lifesciences (EW)
- Close: $83.50 | Daily Change: +$2.28 (+2.81%)
- 6-Month Performance: +0.52% | 52-Week Range: $72.30 - $87.89
- Market Cap: $48.1B | P/E (trailing): 45.14 | P/E (forward): 24.83 | Beta: 0.94
- Analyst Consensus: Buy | Target: $97.15 (range $84-$110, 27 analysts)
- Next Earnings: July 23, 2026 (EPS est: $0.74, Rev est: $1.70B)
- Commentary: Q1 earnings catalyzed the best single-day gain in weeks. Barclays raised its price target, reflecting confidence in TAVR volume stability and the expanding tricuspid/mitral pipeline (EVOQUE, PASCAL). Edwards remains the pure-play structural heart name, but the stock sits ~5% below its 52-week high — the market wants to see sustained execution on newer growth vectors beyond core TAVR. The CLASP II TR and TRISCEND II trials remain key pipeline catalysts.
Medtronic (MDT)
- Close: $80.97 | Daily Change: +$1.60 (+2.02%)
- 6-Month Performance: -8.83% | 52-Week Range: $78.91 - $106.33
- Market Cap: $104.0B | P/E (trailing): 22.62 | P/E (forward): 13.36 | Beta: 0.76
- Analyst Consensus: Buy | Target: $108.00 (range $90-$121, 25 analysts)
- Next Earnings: June 3, 2026 (EPS est: $1.55, Rev est: $9.62B)
- Commentary: Medtronic is trading near its 52-week low, with the stock down nearly 9% over six months — reflecting broader diversified medtech headwinds rather than structural heart-specific issues. The Evolut FX platform remains competitive (today's small-annulus meta-analysis shows SEV advantages on hemodynamics), and the Intrepid TMVR pivotal trial (n=1,056) is recruiting. June 3 earnings will be a key event for structural heart segment visibility. The forward P/E of 13.36 looks attractive if execution improves.
Abbott Laboratories (ABT)
- Close: $90.79 | Daily Change: -$0.54 (-0.59%)
- 6-Month Performance: -25.85% | 52-Week Range: $90.29 - $139.06
- Market Cap: $158.1B | P/E (trailing): 25.43 | P/E (forward): 14.97 | Beta: 0.78
- Analyst Consensus: Buy | Target: $118.64 (range $92-$143, 25 analysts)
- Next Earnings: July 16, 2026 (EPS est: $1.28, Rev est: $12.53B)
- Commentary: Abbott continues its sharp decline, now down over 25% in six months and flirting with 52-week lows. The structural heart division (MitraClip/TriClip) faces competitive pressure from Edwards' PASCAL and EVOQUE systems, while the TRILUMINATE Pivotal's 2-year data — though supportive of a Class IIa ESC recommendation — showed more modest hard outcome benefits than TRISCEND II's replacement approach. The MitraClip G5 registry (not yet recruiting, n=1,000) and REPAIR-MR pivotal trial will be important for re-establishing clinical leadership.
Boston Scientific (BSX)
- Close: $57.61 | Daily Change: +$0.46 (+0.80%)
- 6-Month Performance: -41.57% | 52-Week Range: $56.05 - $109.50
- Market Cap: $85.6B | P/E (trailing): 24.10 | P/E (forward): 15.30 | Beta: 0.78
- Analyst Consensus: Strong Buy | Target: $85.19 (range $60-$110, 32 analysts)
- Next Earnings: July 22, 2026 (EPS est: $0.83, Rev est: $5.40B)
- Commentary: Boston Scientific has been the worst performer in the group, losing over 40% in six months. Its structural heart portfolio remains nascent — the Millipede transcatheter annuloplasty system (4 patients enrolled in feasibility) and the ACURATE neo2 TAVR platform represent long-term bets rather than near-term revenue drivers. The "Strong Buy" analyst consensus reflects belief in BSX's broader electrophysiology and interventional cardiology franchises rather than structural heart specifically. At 15.3x forward earnings, the valuation is increasingly compelling if the broader portfolio delivers.
Anteris Technologies (AVR.AX)
- Close: A$8.15 | Daily Change: +A$0.45 (+5.84%)
- 6-Month Performance: +2.00% | 52-Week Range: A$4.68 - A$9.79
- Market Cap: A$0.8B | P/E (forward): -3.74 (pre-revenue) | Beta: 0.55
- Analyst Target: A$13.00 (1 analyst)
- Commentary: Anteris had its best day in weeks, surging nearly 6% on no specific news catalyst. The DurAVR single-piece TAVR platform, made from 3D-shaped pericardial tissue, represents a genuinely novel approach — but the company remains pre-revenue with a small market cap and a single-analyst coverage universe. High-risk, high-potential speculation on next-generation TAVR architecture. Any clinical data milestone would be a major catalyst (or risk event).
Private Companies of Note: JenaValve Technology (aortic regurgitation TAVR), J Valve Technology (AR-focused TAVR, China), and Meril Life Sciences (Hydra TAVR system, with three actively enrolling European registries) are all privately held. Meril's growing European clinical footprint, evidenced by today's trial updates, suggests potential IPO timing discussions as data mature.
Market Outlook: The structural heart sector is bifurcated — Edwards and Anteris are essentially flat or slightly positive over six months, while the diversified medtech names (Abbott, BSX, Medtronic) have been punished. The divergence likely reflects macro concerns about medtech multiples and tariff/trade uncertainty rather than structural heart-specific pessimism. As ESC 2025 guidelines expand indications for TAVI (≥70), TEER (Class I for SMR), and transcatheter tricuspid therapy (IIa), the volume runway for all major players looks favorable over the next 3-5 years. The near-term question is whether macro headwinds let investors see the forest for the trees.
Clinical Trial Updates
Aortic Valve Trials
- NCT07532733 — Dexmedetomidine Sedation for TAVI
- Status: Recruiting | Phase: N/A | Enrollment: 80
- Sponsor: Erasme University Hospital
- Compares dexmedetomidine vs propofol/remifentanil sedation for TF-TAVI; evaluating respiratory and hemodynamic effects. Relevant to ongoing procedural optimization/minimalist TAVI trends.
- NCT07556523 — Patient Quality of Recovery After TAVR With Different Sedation Regimens
- Status: Recruiting | Phase: Phase 4 | Enrollment: 126
- Sponsor: David Lyubashevsky
- Three-arm comparison: propofol vs dexmedetomidine vs midazolam. Patient-reported recovery outcomes — an underexplored but clinically important endpoint in the minimalist TAVI era.
- NCT06470022 — Evolut FX vs SAPIEN 3 Ultra Resilia
- Status: Recruiting | Phase: N/A | Enrollment: 1,346
- Sponsor: Christian Juhl Terkelsen
- Head-to-head randomized comparison of the two leading contemporary TAVR platforms. This trial directly addresses today's small-annulus meta-analysis question — with contemporary devices, do hemodynamic differences translate to clinical outcomes? Results will be practice-changing.
- NCT05956652 — Hydra Registry (Italy)
- Status: Recruiting | Phase: N/A | Enrollment: 500
- Sponsor: Sahajanand Medical Technologies (Meril Life Sciences)
- NCT06342635 — Hydra Single-Centre Experience (Copenhagen)
- Status: Recruiting | Phase: N/A | Enrollment: 50
- Sponsor: Sahajanand Medical Technologies
- NCT06507579 — Hydra Registry (UK)
- Status: Recruiting | Phase: N/A | Enrollment: 250
- Sponsor: Sahajanand Medical Technologies
- NCT06171802 — EMPagliflozin After Aortic Valve Replacement
- Status: Active, Not Recruiting | Phase: Phase 4 | Enrollment: 205
- Sponsor: Rigshospitalet, Denmark
- Testing SGLT2i after AVR — an interesting intersection of HF pharmacotherapy and structural intervention. Could inform whether post-procedural medical optimization improves remodeling.
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 1,000
- Sponsor: NHLBI
- Advanced CT reconstruction techniques — relevant to preprocedural TAVR planning and valve failure imaging.
- [LANDMARK] NCT02701283 — Evolut Low Risk (Long-Term Follow-Up)
- Status: Active, Not Recruiting | Enrollment: 2,223
- Sponsor: Medtronic Cardiovascular
- Long-term data from this pivotal trial directly informed the ESC 2025 age-threshold shift to TAVI at ≥70. Extended follow-up beyond 5 years will be critical for the durability debate.
Mitral Valve — Repair Trials
- [LANDMARK] NCT04198870 — REPAIR-MR (MitraClip vs Surgery for Primary MR)
- Status: Active, Not Recruiting | Enrollment: 500
- Sponsor: Abbott Medical Devices
- The pivotal head-to-head trial of TEER vs surgical repair for primary MR. Both ACC/AHA and ESC currently rate TEER as subordinate to surgery for PMR — REPAIR-MR could change that paradigm. Results are eagerly awaited.
- [LANDMARK] NCT05051033 — PRIMATY (MitraClip vs Medical Therapy for Secondary MR)
- Status: Recruiting | Enrollment: 450
- Sponsor: Annetine Gelijns
- Will help clarify whether TEER benefit for ventricular SMR extends beyond COAPT-like patients, particularly comparing surgical repair vs TEER vs medical therapy. A critical ongoing trial.
- [LANDMARK] NCT03706833 — COAPT (Long-Term Follow-Up)
- Status: Active, Not Recruiting | Enrollment: 1,247
- Sponsor: Edwards Lifesciences (now including PASCAL system)
- The foundational trial for TEER in ventricular SMR. 5-year data drove the ESC 2025 upgrade to Class I. Extended follow-up continues to be the anchor for guideline recommendations.
- NCT07543874 — MitraClip G5 Registry
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 1,000
- Sponsor: University Hospital of Cologne
- Large European registry for the next-generation MitraClip G5 platform — will provide first real-world data on iterative device improvements.
- NCT04147884 — Millipede Transcatheter Annuloplasty Ring System
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 4
- Sponsor: Boston Scientific
- Feasibility study for a transcatheter mitral annuloplasty ring. With only 4 patients enrolled and no further recruitment, this program appears stalled — raising questions about Boston Scientific's mitral repair strategy.
- NCT07086534 — GeminiOne TEER System (Severe MR)
- Status: Recruiting | Phase: N/A | Enrollment: 15
- Sponsor: Sierra Valve LLC
- Early-stage feasibility study of a novel TEER device — the competitive landscape beyond MitraClip and PASCAL continues to expand.
Mitral Valve — Replacement Trials
- [LANDMARK] NCT03242642 — Intrepid TMVR Pivotal
- Status: Recruiting | Enrollment: 1,056
- Sponsor: Medtronic Cardiovascular
- The largest ongoing TMVR pivotal trial. Medtronic's Intrepid system represents one of the most advanced attempts at reliable transcatheter mitral replacement — success here would reshape the field.
Tricuspid Valve — Repair Trials
- [LANDMARK] NCT03904147 — TRILUMINATE Pivotal (TriClip for TR)
- Status: Active, Not Recruiting | Enrollment: 572
- Sponsor: Abbott Medical Devices
- The trial that established transcatheter tricuspid repair as an ESC IIa recommendation. 2-year data showed QoL improvement and HF hospitalization reduction. Longer follow-up and comparison with TTVR outcomes will be critical.
- [LANDMARK] NCT04097145 — CLASP II TR (PASCAL for TR)
- Status: Recruiting | Enrollment: 870
- Sponsor: Edwards Lifesciences
- Edwards' pivotal tricuspid TEER trial — head-to-head with optimal medical therapy. Results will determine whether PASCAL can match TriClip's regulatory success in the tricuspid space.
Tricuspid Valve — Replacement Trials
- [LANDMARK] NCT04482062 — TRISCEND II (Evoque Tricuspid Replacement)
- Status: Active, Not Recruiting | Enrollment: 864
- Sponsor: Edwards Lifesciences
- The pivotal TTVR trial. Today's Canadian Evoque registry data are consistent with the pivotal experience. TTVR achieves more complete TR elimination than repair, but with higher device-related complications. Ongoing follow-up will clarify the repair-vs-replacement tradeoff.
Other Relevant Trials
- NCT06655480 — Triple Combination Therapy (ARNI + SGLT2i + MRA) in Advanced HFpEF
- Status: Recruiting | Phase: Phase 2 | Enrollment: 50
- Sponsor: National Medical Research Center for Cardiology, Russia
- Relevant to the structural heart community given the overlap between HFpEF and atrial functional MR/TR — optimized medical therapy is the foundation upon which device decisions should be made.
- NCT03152773 — MRI-Guided Heart Catheterization
- Status: SUSPENDED | Enrollment: 22
- Sponsor: NHLBI
- MRI fluoroscopy with passive guidewires — a forward-looking imaging approach. Suspension noted; reason unclear.
Social & Conference Highlights
No major conference presentations or notable social media discussions tracked today. The next major valve meeting on the horizon is EuroPCR (May 2026, Paris), where late-breaking data from several ongoing tricuspid and TAVR trials are anticipated.
Closing Thought: Today's ALERT trial in JACC is a powerful reminder that in 2026, the biggest barrier to appropriate valve care often isn't the device, the operator, or the guideline — it's the referral. An automated EHR alert costing essentially nothing achieved a 27% relative improvement in the composite of evaluation and treatment across 35 hospitals. Before we debate which transcatheter valve to implant, we should make sure patients who need valve therapy are actually being seen. Sometimes the most impactful innovation is the simplest one.
— E. Nolan Beckett, The Valve Wire