Week in Review

The biggest story this week is a regulatory one: CMS has opened a formal National Coverage Analysis for TAVR (CAG-00430R2), a process that could redefine which American patients qualify for Medicare-covered transcatheter aortic valve replacement — with enormous implications for procedure volumes, reimbursement, and patient access. In the tricuspid valve space, three separate companies — TRiCares, VDyne, and Edwards Lifesciences — made headlines: TRiCares and VDyne both received FDA clearances to advance their transcatheter tricuspid valve replacement systems into pivotal trials, while emerging TRISCEND II data hint at a possible mortality benefit with Edwards' Evoque system at two years. On the clinical research front, a JACC: Cardiovascular Interventions study stress-tested the new ESC tricuspid guidelines against real-world registry data and found that patients the guidelines would exclude from transcatheter treatment still experience meaningful symptom relief — a provocative finding that challenges clean exclusion criteria. Meanwhile, MiRus began enrolling patients in a randomized trial of its novel Siegel transcatheter aortic valve, Anteris Technologies scaled its DurAVR pivotal trial to 1,650 patients, and JenaValve highlighted early US commercial use of the Trilogy TAVR system for aortic regurgitation. Markets remain under pressure heading into a critical earnings stretch: Abbott reports April 16, followed by Edwards Lifesciences and Boston Scientific on April 22.

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Top Stories This Week

[NOTABLE] CMS Opens National Coverage Analysis for TAVR — A Potential Watershed for US Reimbursement

The Centers for Medicare & Medicaid Services formally initiated a reconsideration of the national coverage determination for TAVR (CAG-00430R2). The current NCD, last substantively updated in 2019 following low-risk trial approvals, mandates specific patient selection criteria and participation in the STS/ACC TVT Registry. This review arrives at a critical juncture: the 2025 ESC/EACTS guidelines have lowered the TAVI-preferred age threshold to ≥70, EARLY TAVR data support intervention in asymptomatic severe AS (ESC Class IIa), and TAVR volumes continue expanding into lower-risk populations. Key questions for the review include whether CMS will expand coverage to asymptomatic patients, how it will address the divergent ACC/AHA (65–80 shared decision zone) and ESC (≥70 TAVI-preferred) age frameworks, and whether TVT Registry requirements will evolve. The NCA process typically takes 6–12 months and includes a public comment period. All stakeholders — clinicians, hospitals, device manufacturers, and patient groups — should prepare to engage. This is the most consequential US regulatory development for TAVR since coverage expansion for low-risk patients.

[NOTABLE] Tricuspid Valve Replacement Race Intensifies: Three Major Milestones in One Week

The transcatheter tricuspid valve replacement (TTVR) landscape shifted dramatically this week. TRiCares received FDA IDE approval to launch a pivotal trial for its TTVR system. VDyne secured FDA clearance for its pivotal VISTA-US trial, and registered a bold 730-patient head-to-head study (TRIVITA) comparing its TTVR system directly against Edwards' Evoque. And TCTMD reported emerging signals of a mortality benefit with Edwards' Evoque system (TRISCEND II) at two years — a finding that, if confirmed, would be the first survival signal for any transcatheter tricuspid device. This all unfolds against the backdrop of the 2025 ESC/EACTS guidelines giving transcatheter TR treatment a Class IIa recommendation — a category that did not exist in the 2020 ACC/AHA guidelines. The pace of competition is extraordinary, but the evidence base remains young. TRISCEND II's earlier reports flagged higher bleeding and pacemaker rates, and the "mortality hint" requires full peer-reviewed disclosure before it should influence practice. A separate Cardiovascular Business report highlighted that paravalvular leak after TTVR is linked to much lower survival — underscoring the importance of procedural precision.

[NOTABLE] ESC Tricuspid Guidelines Tested Against Real-World Registry Data

Stolz et al. applied the 2025 ESC/EACTS guideline exclusion criteria to 1,626 tricuspid TEER patients from the EuroTR registry (JACC: Cardiovascular Interventions). Approximately 13.1% would have been classified as "optimal medical therapy only" candidates — patients the guidelines say should not receive transcatheter intervention due to severe LV dysfunction, RV dysfunction, or precapillary pulmonary hypertension. These excluded patients had significantly worse HF hospitalization-free survival (~59% vs. ~74%, P<0.001), but achieved comparable rates of NYHA class improvement (56% vs. 60%, P=0.68). This creates a genuine dilemma: the guidelines correctly identify higher-risk patients, but the symptom relief appears similar. Without randomized data in this subgroup, we cannot know whether the procedure is providing meaningful palliation or futile intervention. The study underscores the need for multidisciplinary Heart Team evaluation rather than rigid algorithmic exclusion — a nuance both guidelines endorse in principle but that can be lost in practice.

[NOTABLE] New TAVR Competitors Enter Randomized Trials

MiRus commenced enrollment in the STAR randomized trial (n=1,025) of its Siegel transcatheter aortic valve, directly challenging the Edwards SAPIEN and Medtronic Evolut platforms. Simultaneously, Anteris Technologies scaled its DurAVR pivotal trial to 1,650 patients — the largest pivotal for any next-generation TAVR device. Abbott's balloon-expandable TAVI first-in-human study (n=8) completed enrollment, signaling Abbott's intent to compete in a market it has ceded to Edwards. The TAVR competitive landscape is broadening, though Edwards and Medtronic remain dominant. For clinicians, the key question remains durability: novel valve designs and tissue treatments (ADAPT, RESILIA) promise longer-lasting devices, but none have demonstrated superiority beyond 5 years of follow-up.

JenaValve Highlights Early Commercial Trilogy Use for Aortic Regurgitation

JenaValve Technology (TipRanks) announced early US commercial experience with its Trilogy TAVR system specifically for native aortic regurgitation — a condition that has historically had no transcatheter option. The 2025 ESC/EACTS guidelines now include TAVI for AR as Class IIb for inoperable patients with suitable anatomy, creating a formal indication where none existed before. JenaValve's locator-based anchoring technology is uniquely designed for the non-calcified annulus typical of pure AR, giving it potential first-mover advantage. The ALIGN-AR LVAD Registry (n=50) is actively recruiting. While still very early in commercialization, this represents a meaningful advance for patients with severe AR who cannot undergo surgery.

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Aortic Valve (TAVR/TAVI)

New-Onset LBBB Impairs Cardiac Reverse Remodeling After TAVR

Wang et al. (Journal of Cardiothoracic Surgery) analyzed 101 TAVR patients and found that the 27.7% who developed new-onset persistent LBBB showed increased LV dimensions, higher LV mass index, and reduced LVEF at 6 months — the opposite of expected reverse remodeling. Most concerning: mitral regurgitation initially improved at 1 month but worsened again by 6 months in the LBBB group, while the no-LBBB group maintained improvement. THV implantation depth was the key modifiable risk factor. This small, single-center, retrospective study nonetheless reinforces that new LBBB after TAVR is not benign — dyssynchronous contraction progressively distorts mitral valve geometry. The ESC 2025 guidelines emphasize conduction disturbances among TAVR's most significant complications. Both cusp-overlap and three-cusps coplanar deployment techniques, studied in a separate publication this week, aim to reduce this problem.

HFrEF vs. HFpEF Outcomes After TAVR: 120,000-Patient Analysis

Dixit et al. (Current Problems in Cardiology) analyzed 120,199 TAVR patients from the NRD (2016–2022) and found that HFrEF (16.25% of the cohort) was associated with significantly higher rates of virtually every in-hospital complication — cardiogenic shock, mechanical circulatory support, ECMO, acute kidney injury, acute MI, ventilation — plus higher in-hospital mortality and 30-day readmission (11.29% vs. 9.74%, HR 1.14). This is clinically intuitive but critically important as TAVR potentially expands to patients with moderate AS and systolic heart failure (the TAVR-UNLOAD paradigm). That trial failed its primary composite endpoint. This NRD analysis reinforces that HFrEF patients represent a fundamentally higher-risk TAVR population regardless of AS severity.

Navitor vs. Evolut PRO: Paravalvular Leak Advantage for Intra-Annular Design

The FIRE TAVI study (Clinical Research in Cardiology), a multicenter retrospective comparison of 269 Navitor and 272 Evolut PRO implants, found comparable safety composites (adjusted OR 0.97) and pacemaker rates, but significantly less moderate-or-greater paravalvular leak with Navitor (0.8% vs. 3.5%, P=0.032). This PVL reduction is consistent with Navitor's intra-annular sealing design. However, the study is retrospective without randomization or core-lab PVL adjudication. Moderate-or-greater PVL is consistently associated with worse survival, making this finding clinically relevant if confirmed in larger, prospective datasets.

Nutritional Status Matches Complex Scores for TAVR Risk Stratification

Two converging publications established the Geriatric Nutritional Risk Index (GNRI) — calculable from just five variables — as comparable to EuroSCORE II and STS-PROM for predicting post-TAVR mortality. Boehm et al. analyzed 3,470 TAVR patients and found no statistical difference in AUC between GNRI and either established score (0.72 vs. 0.69 vs. 0.72). Liu et al. confirmed in a meta-analysis of 9,647 patients that low GNRI predicts 90% higher all-cause mortality (HR 1.90). GNRI's simplicity is appealing as a complementary screening tool, though AUC values in the 0.69–0.72 range reflect only moderate discrimination across all three scores.

Machine Learning Predicts Periprocedural Events in Bicuspid TAVR

A multicenter machine learning model (Open Heart) from 1,266 BAV TAVR patients identified five predictors of periprocedural adverse events: Type 0 morphology, aortic root calcification volume, horizontal aorta, annular ellipticity, and prior AF. AUC was 0.801, with event rates ranging from 0.6% (lowest quartile) to 9.6% (highest). Both ACC/AHA 2020 (Class IIb) and ESC 2025 (Class IIb) maintain BAV as primarily surgical territory — BAV patients were excluded from virtually all major TAVR-SAVR RCTs. NOTION 2's BAV subset showed a numerically higher event rate with TAVI (HR 3.8, P=0.07). This model should be used to identify BAV patients who may be better served by surgery, not simply to optimize transcatheter technique.

Cardiac Rehab After TAVI: Only 4.4% Attend

A whole-population English study (Heart) of 24,925 TAVI recipients (2018–2023) found that only 1,090 (4.4%) attended cardiac rehabilitation. CR was associated with lower all-cause rehospitalization (HR 0.88) and non-cardiovascular rehospitalization (HR 0.84), but no significant mortality benefit. A 4.4% participation rate is remarkably low and raises systemic questions about post-TAVI care pathways.

Leadless vs. Transvenous Pacemakers Post-TAVR

A meta-analysis of six retrospective studies (10,681 patients, 874 leadless) found that leadless pacemakers after TAVR reduced device complications (RR 0.46) and vascular access complications (RR 0.15), but carried a higher 2-year mortality signal (RR 1.61, P=0.047). The authors attribute this to selection bias. No randomized data exist; the post-TAVR pacemaker selection question needs prospective investigation.

LVOT Obstruction After TAVI in Severe LVH

Yoshiga et al. (A&A Practice) report acute pulmonary congestion from dynamic LVOT obstruction with SAM following TAVI in a patient with marked LVH. This rare but catastrophic complication — LVEDP rose to 35 mmHg requiring reintubation — highlights the importance of pre-procedural assessment of LVH severity and mitral-septal distance in patients with small ventricular cavities.

LA Functional Recovery Precedes Structural Remodeling After TAVI

Li et al. (Scientific Reports) prospectively tracked 162 TAVI patients and found that LA strain improved at 1 month while absolute LA volumes didn't decrease until 6 months — suggesting speckle-tracking echocardiography may be a more sensitive early marker of hemodynamic benefit than volumetric measurements.

Sex-Specific CT Predictors of Pulmonary Hypertension After TAVI

Boxhammer et al. (Insights into Imaging) found that the MPA/AA ratio predicted survival in men (HR 1.857, P=0.006) but not women among 526 TAVI patients — reinforcing the need for sex-specific imaging thresholds in structural heart disease.

Periaortic Fat Attenuation as Post-TAVR Mortality Marker

Brendel et al. (JACC: Cardiovascular Imaging) report that opportunistic CT-derived periaortic fat attenuation — a measure of perivascular inflammation obtainable from routine pre-TAVR scans — predicts mortality. If validated, this zero-cost imaging biomarker could complement existing risk stratification.

Additional Aortic Studies This Week

• Obata et al. — Urinary L-FABP as point-of-care AKI predictor after TAVI (AUC 0.74, n=186)
• Emini et al. — Valve-in-valve-in-valve case: platform switching from balloon-expandable to self-expanding as rescue strategy
• Jia et al. — Qualitative study on digital home-based cardiac rehabilitation after TAVR
• Androshchuk et al. (JAHA) — Wearable activity monitoring shows cardiac damage staging predicts physical activity recovery post-TAVI
• Mengesha et al. (Circulation: Cardiovascular Imaging) — Comprehensive review on imaging in clinical trials of aortic valve intervention
• Panaou et al. — Multi-omics study linking diastolic dysfunction in TAVI patients to disrupted mitochondrial lipids and metabolic dysfunction
• Systematic review — No significant difference in aortic growth rates between BAV and tricuspid patients after valve replacement
• JTCVS study — Membranous septum length and valve calcification predict pacemaker need after SAVR (n=425)
• Journal of Physiology — Fluid-structure interaction models of aortic valve validated against 4D flow MRI in pre-TAVR patients
• Cardiovascular Intervention and Therapeutics — Post-TAVI valve orifice assessment by TEE
• Journal of Cardiothoracic Surgery — Transcarotid TAVR with balloon-expandable valves

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Mitral Valve (Repair & Replacement)

AI-Enhanced Imaging for Mitral TEER

Hahn et al. (JACC: Case Reports) described DeviceGuide, an AI software platform that automatically tracks M-TEER devices within 3D TEE volumes in real time, generating multiplanar-reconstructed images without manual reformatting. If validated at scale, this could flatten the learning curve for M-TEER — particularly relevant as the ESC 2025 guidelines upgraded TEER for ventricular secondary MR to Class I (LOE A), which will drive procedure volumes to lower-experience centers. However, procedural simplification must not outpace operator training and patient selection rigor.

ICARUS: Clip-Based Annular Reduction as Bridge to TMVR

A JACC publication describes the ICARUS concept — using TEER clips to intentionally reduce the mitral annular dimension as a bridge to subsequent TMVR. This creative staged approach acknowledges a central TMVR challenge: the annulus is often too large for current replacement devices. While conceptually intriguing, a two-procedure strategy raises questions about cumulative risk, residual stenosis after clipping, and whether this is justified when surgical options exist. This approach is most defensible for truly inoperable patients.

M-TEER Resolves Hemolytic Anemia After Surgical Repair

Scheffler et al. (JACC: Case Reports) describe TEER resolving severe hemolytic anemia from recurrent eccentric MR after prior surgical repair — illustrating TEER's role as a complementary bailout technology for failed surgery in prohibitive-risk patients.

Frailty and Mitral TEER Outcomes

Jain et al. (Catheterization and Cardiovascular Interventions) published a propensity-matched analysis examining frailty's impact on M-TEER outcomes. As TEER expands under the ESC's Class I upgrade for secondary MR, the field needs validated frailty cutoffs to prevent indication creep into populations unlikely to benefit. The COAPT criteria excluded patients with advanced HF — a population that substantially overlaps with the frail.

Hybrid Mitral Repair: TEER + CABG + LAAO

Uchimuro et al. (MMCTS) described a two-stage hybrid approach for an 84-year-old with ischemic MR, ACS, and chronic AF: initial M-TEER followed by surgical CABG with LAAO. This illustrates the evolving interplay between transcatheter and surgical modalities, using each where it offers the best risk-benefit ratio in complex multimorbid patients.

Iatrogenic ASD Closure After Mitral TEER

A Cureus publication revisited the MITHRAS trial concept for percutaneous closure of iatrogenic ASDs following mitral TEER — a practical procedural consideration as mitral TEER volumes increase.

KingstronBio ProStyle M® TMVR: First Implant in China

KingstronBio announced its first ProStyle M® transcatheter mitral valve implant in a Chinese multicenter confirmatory study, adding another entrant to the global TMVR pipeline alongside Medtronic's Intrepid and Edwards' SAPIEN M3.

India: Simultaneous TAVI + TMVR

Knocksense reported India's first combined TAVI and TMVR at Jaipur's Eternal Hospital — a niche but growing frontier for simultaneous multi-valve transcatheter intervention.

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Tricuspid Valve (Repair & Replacement)

TRISCEND II: Emerging Mortality Signal at 2 Years

As detailed in Top Stories, TCTMD reports hints of a mortality benefit with Evoque TTVR (TRISCEND II) at 2 years. Full peer-reviewed data and endpoint adjudication are awaited. If confirmed, this would be the first survival signal for any transcatheter tricuspid device — a qualitative leap beyond the QoL and HF hospitalization endpoints that drove the ESC 2025 Class IIa recommendation. But "hints" is not a confirmed primary endpoint hit, and TRISCEND II has noted higher procedural complication rates.

Minimalist Evoque TTVR Under Conscious Sedation

Rajagopal et al. (JACC: Case Reports) reported the first Evoque TTVR performed under conscious sedation with 3D ICE alone — no general anesthesia, no TEE. This mirrors TAVR's minimalist evolution. A single case, but it signals procedural simplification potential for a frail patient population.

LBBAP After TTVR: First Systematic Report

JACC: Case Reports described the first two cases of left bundle branch area pacing (LBBAP) after TTVR in patients who developed high-grade AV block. LBBAP avoids lead interaction with tricuspid prosthetic leaflets — a critical advantage given that pacemaker implantation occurs in up to 24.7% of TTVR patients. At 30 days, pacing parameters were stable with no valve compromise. Proof-of-concept only, but an important avenue for managing TTVR's most common complication.

TREY Registry: TR Prevalence and Phenotyping

Abdelghani et al. (Cardiology) presented the TREY Registry (n=435 patients ≥60): 42% had mild TR and 16% had moderate/severe TR. A novel TH/AD ratio (tenting height/annular diameter) differentiated ventricular from atriogenic functional TR with high accuracy (AUC 0.94). This distinction matters for treatment selection: atriogenic TR may respond differently to annuloplasty or TEER than ventricular TR with significant tethering. Mortality was significantly higher only at moderate/severe severity, reinforcing early intervention.

PVL After TTVR Linked to Lower Survival

Cardiovascular Business reported that paravalvular leak after TTVR is associated with substantially lower survival and fewer clinical benefits — underscoring the importance of procedural precision and appropriate patient/device sizing in tricuspid replacement.

TriClip Japan Post-Approval Study

The TriClip Japan Post-Approval Study (NCT07509658, n=250) is now actively recruiting. This post-market surveillance is important for understanding how tricuspid TEER performs in Japanese patients, whose anatomy and body habitus may differ from Western populations studied in TRILUMINATE.

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Surgical vs. Transcatheter Comparisons

Lifetime Valve Management and Economic Forces Behind TAVR Expansion

Mainali and Pope (Annals of Thoracic Surgery) published a commentary directly challenging the economic forces driving TAVR into younger patients. This joins a growing chorus — Bowdish, Badhwar, Mehaffey, Kaul, Miller, Chikwe, and others — questioning whether financial incentives (shorter stays, higher volumes, device pricing) are pulling TAVR toward younger patients faster than the science supports. The ESC 2025 guidelines recommend SAVR for patients under 70 precisely because THV explantation carries 12–17% mortality and lifetime management remains a critical unknown. The recently published meta-analysis by Khan et al. showing 20% TAVR mortality reduction at 5 years in lower-risk patients is provocative — but as the reference editorial "From the Hazards of Death to the Hazards of Indication Creep for TAVR" notes, when intermediate-risk trials are excluded, the mortality difference disappears.

Polymeric Heart Valves Editorial

Shirai et al. (JACC: Asia) raised the possibility that polymeric THVs could address the durability ceiling of current bioprosthetic TAVR devices. If polymeric leaflets can match or exceed tissue durability without anticoagulation requirements, they would be transformative for younger patients. But this is early-stage, and the history of cardiac biomaterials is littered with promising concepts that failed at scale.

Annular Rupture and On-Site Cardiac Surgery

A commentary in Journal of Cardiothoracic Surgery revisited annular rupture during TAVI and the importance of on-site surgical backup. The TRACS trial (n=657) and a Polish randomized trial (n=404) are both addressing whether TAVI can be safely performed without on-site surgery. Annular rupture occurs in 0.5–1.5% of cases with 25–50% mortality.

Anomalous Coronary Anatomy in Valve Interventions

Furukawa et al. (Annals of Thoracic Surgery) highlighted the catastrophic ischemia risk from anomalous retro-aortic left circumflex artery during both SAVR and TAVR — a reminder that anatomic due diligence cannot be shortcut, especially as TAVR expands to lower-risk populations.

TAVR Explantation Discussion

The Good Men Project published a patient-facing article featuring cardiac surgeons discussing TAVR failure options. Recent data show redo-TAVR accounts for 84% of reinterventions (only 1.7% at 8 years), while explantation carries 12–17% mortality. The ESC 2025 guidelines now emphasize lifetime management planning at the index procedure — a conversation that must happen before the first valve, not after failure.

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Clinical Trials Update

Aortic Valve

• NCT02701283 — Evolut Low Risk (Long-term Follow-up) [LANDMARK] | Status: Active, not recruiting | Enrollment: 2,223 | Sponsor: Medtronic | The longest-running low-risk TAVR RCT. Data beyond 5 years were central to the ESC 2025 decision to lower the TAVI-preferred threshold to ≥70. Updated March 2026.
• NCT07278310 — STAR Trial (Siegel TAVR) | Status: Recruiting | Enrollment: 1,025 | Sponsor: MiRus | Randomized trial of a novel TAVR device. Updated April 9, 2026.
• NCT07194265 — DurAVR THV Pivotal Trial | Status: Recruiting | Enrollment: 1,650 | Sponsor: Anteris Technologies | The largest next-generation TAVR pivotal, comparing DurAVR against SAPIEN and Evolut series. Updated April 8, 2026.
• NCT05712161 — DurAVR Early Feasibility Study | Status: Active, not recruiting | Enrollment: 15 | Sponsor: Anteris Technologies | Updated April 8, 2026.
• NCT07082426 — Abbott Balloon-Expandable TAVI FIH | Status: Active, not recruiting | Enrollment: 8 | Sponsor: Abbott | Abbott's entry into balloon-expandable TAVR. Updated April 8, 2026.
• NCT05751577 — TRACS Trial (TAVI ± On-Site Surgery) | Status: Active, not recruiting | Enrollment: 657 | Sponsor: Azienda USL di Bologna | Updated April 8, 2026.
• NCT07515768 — TAVI Without On-Site Surgery (Poland) | Status: Not yet recruiting | Enrollment: 404 | Sponsor: Medical University of Warsaw | Updated April 7, 2026.
• NCT06557798 — REdo TAVI (REVALVE) | Status: Recruiting | Enrollment: 550 | Sponsor: Leeds Teaching Hospitals NHS | Three-arm trial: TAV-in-TAV vs. surgical explant vs. conservative management. Updated April 6, 2026.
• NCT07343674 — PERFECT Registry (Evolut FX+) | Status: Recruiting | Enrollment: 500 | Sponsor: Portuguese Association of Interventional Cardiology | Updated April 8, 2026.
• NCT06589063 — TAVR in Severe Low-Flow Low-Gradient AS | Status: Recruiting | Enrollment: 1,350 | Sponsor: University of Salerno | Updated April 7, 2026.
• NCT06953206 — SAPIEN 3 Ultra RESILIA Long-Term Evaluation | Status: Not yet recruiting | Enrollment: 500 | Sponsor: Institut für Pharmakologie und Präventive Medizin | Edwards' durability play. Updated earlier.
• NCT07509554 — PREDICT (Pressure-Based Post-TAVI Assessment) | Status: Not yet recruiting | Enrollment: 100 | Sponsor: Istanbul Mehmet Akif Ersoy Hospital | Updated April 3, 2026.
• NCT06197503 — Conduction System vs. RV Pacing Post-TAVI | Status: Recruiting | Enrollment: 48 | Sponsor: Hospital Clinic of Barcelona
• NCT07519161 — Pharmacological Intervention to Prevent NOAF After TAVR | Status: Not yet recruiting | Enrollment: 198 | Sponsor: Shanghai East Hospital | Metoprolol vs. amiodarone. Updated April 9, 2026.
• NCT07511673 — Dental Screening Before Valve Surgery/TAVI | Status: Not yet recruiting | Enrollment: 1,300 | Sponsor: Region Skåne | Updated April 6, 2026.
• NCT06594705 — JenaValve ALIGN-AR LVAD Registry | Status: Recruiting | Enrollment: 50 | Sponsor: JenaValve Technology | Trilogy system for AR in LVAD patients. Updated April 1, 2026.

Mitral Repair

• NCT04198870 — REPAIR-MR (MitraClip vs. Surgery for Primary MR) [LANDMARK] | Status: Active, not recruiting | Enrollment: 500 | Sponsor: Abbott | The definitive TEER vs. surgical repair trial. Updated November 2025.
• NCT05051033 — PRIMATY [LANDMARK] | Status: Recruiting | Enrollment: 450 | Sponsor: Annetine Gelijns | TEER vs. surgical MV repair for secondary MR. Updated March 2026.
• NCT03706833 — Edwards PASCAL CLASP IID/IIF [LANDMARK] | Status: Active, not recruiting | Enrollment: 1,247 | Sponsor: Edwards Lifesciences | PASCAL vs. MitraClip head-to-head. Updated April 9, 2026.
• NCT04097145 — Edwards PASCAL Pivotal | Status: Recruiting | Enrollment: 870 | Sponsor: Edwards Lifesciences | Updated April 6, 2026.

Mitral Replacement

• NCT03242642 — Intrepid TMVR Pivotal [LANDMARK] | Status: Recruiting | Enrollment: 1,056 | Sponsor: Medtronic Cardiovascular | The largest TMVR trial globally. Updated March 2026.
• NCT07501234 — MitraFix® First-in-Human | Status: Recruiting | Enrollment: 5 | Sponsor: Mitrassist Lifesciences

Tricuspid Repair

• NCT03904147 — TRILUMINATE Pivotal (TriClip) [LANDMARK] | Status: Active, not recruiting | Enrollment: 572 | Sponsor: Abbott | The foundational trial for tricuspid TEER. Updated December 2024.
• NCT07509658 — TriClip Japan Post-Approval Study | Status: Recruiting | Enrollment: 250 | Sponsor: Abbott | Updated April 3, 2026.

Tricuspid Replacement

• NCT04482062 — TRISCEND II (Evoque) [LANDMARK] | Status: Active, not recruiting | Enrollment: 864 | Sponsor: Edwards Lifesciences | Hints of mortality benefit at 2 years. Updated February 2026.
• NCT07516444 — TRIVITA Pivotal (VDyne vs. Evoque) [NEW] | Status: Not yet recruiting | Enrollment: 730 | Sponsor: VDyne | First head-to-head TTVR comparison. Updated April 8, 2026.
• NCT05848284 — VISTA-US (VDyne Early Feasibility) | Status: Recruiting | Enrollment: 30 | Sponsor: VDyne
• NCT07516145 — Robotic Transjugular TTVR | Status: Recruiting | Enrollment: 10 | Sponsor: Prince of Wales Hospital, Hong Kong | Updated April 7, 2026.

Other Notable Trials

• NCT05372627 — NHLBI-Emory Advanced CT | Status: Not yet recruiting | Enrollment: 1,000 | Updated April 9, 2026.
• NCT07520656 — TAVI/MV Repair Impact on Sleep-Disordered Breathing | Status: Recruiting | Enrollment: 150 | Updated April 9, 2026.
• NCT03152773 — MRI-Guided Heart Catheterization | Status: Suspended | Enrollment: 22 | Updated April 7, 2026.

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Valve Industry Stocks — Weekly Performance

The structural heart sector closed the week under continued pressure from broader market volatility, with four of five tracked companies finishing lower. The fundamental disconnect between analyst targets and market prices remains the defining feature of this moment: clinical momentum has never been stronger (ESC 2025 guideline expansions, new device approvals, multiple pivotal trials launching), yet stocks are near 52-week lows. Earnings over the next two weeks — Abbott (April 16), Edwards and Boston Scientific (April 22) — will determine whether this is a buying opportunity or a prelude to estimate revisions.

Edwards Lifesciences (EW)

• Close (4/10): $77.87 | Weekly Change: -$3.18 (-3.92%)
• 6-Month Performance: +$4.92 (+6.74%)
• Market Cap: $45.2B | P/E (trailing): 43.02 | P/E (forward): 23.50 | Beta: 0.94
• 52-Week Range: $68.63 – $87.89
• Analyst Target: $96.93 (range $84.00 – $110.00, 27 analysts) — Buy
• Next Earnings: April 22, 2026 | EPS est: $0.73 | Revenue est: $1.60B
• Key This Week: Goldman Sachs raised its target to $97. CFO Scott Ullem sold ~$1.04M in shares (10b5-1 plan). CMS NCA reconsideration introduces regulatory uncertainty. TRISCEND II mortality hints are bullish for the Evoque franchise. Stock traded down 3.9% for the week heading into earnings. The 24.5% gap between current price and analyst consensus suggests significant upside if Q1 delivers.

Medtronic (MDT)

• Close (4/10): $87.21 | Weekly Change: +$0.58 (+0.67%)
• 6-Month Performance: -$6.90 (-7.34%)
• Market Cap: $112.0B | P/E (trailing): 24.36 | P/E (forward): 14.38 | Beta: 0.76
• 52-Week Range: $79.93 – $106.33
• Analyst Target: $109.64 (range $91.00 – $125.00, 25 analysts) — Buy
• Next Earnings: May 20, 2026 | EPS est: $1.54 | Revenue est: $9.62B
• Key This Week: The only gainer among the majors this week (+0.67%). Evolut Low Risk long-term data remain pivotal for the age threshold debate. Intrepid TMVR (n=1,056) and PERFECT Registry (Evolut FX+, n=500) are actively recruiting. At a forward P/E of 14.4, MDT is the most value-oriented name in the group. Reports May 20 — later than peers, giving management visibility into competitors' results.

Abbott Laboratories (ABT)

• Close (4/10): $100.30 | Weekly Change: -$2.57 (-2.50%)
• 6-Month Performance: -$29.84 (-22.93%)
• Market Cap: $174.3B | P/E (trailing): 26.96 | P/E (forward): 16.42 | Beta: 0