Executive Summary
Today's valve wire centers on a practical question every TAVR operator faces: what happens after you commit a patient to a permanent pacemaker? A LANDMARK trial sub-study finds that nearly 1 in 5 patients who receive a pacemaker after TAVI recover conduction within a year — but atrial fibrillation dramatically reduces the odds of that recovery. Meanwhile, a novel CMR-derived marker of left atrioventricular remodeling shows promise for risk-stratifying TAVR candidates, and an unusual case report highlights the real-world challenge of implanting bovine bioprostheses in patients with alpha-gal allergy. On the industry side, Edwards Lifesciences holds steady while Boston Scientific and Abbott continue steep six-month slides, and Anteris Technologies advances its DurAVR pivotal trial in the US.
For the clinical audience: the LANDMARK pacemaker recovery data (published in International Journal of Cardiology) deserve close attention. The 18% recovery rate across all three THV platforms — Myval, SAPIEN, and Evolut — is consistent with prior single-platform studies, but the finding that atrial fibrillation drops recovery odds by over 90% has immediate implications for post-TAVI pacemaker interrogation protocols and the ongoing debate about whether early device implantation is being performed too aggressively. Separately, a comprehensive electrophysiology-focused review of tricuspid valve interventions underscores the growing recognition that conduction system injury is not just a TAVR problem — it is central to the tricuspid device landscape as well. And a European Heart Journal Imaging sub-journal publication introduces the left atrioventricular coupling index (LACI) as a potential pre-TAVR risk marker, though the small, single-center cohort warrants the usual caveats.
Today's Key Findings
- [NOTABLE] Pacemaker Recovery After TAVI (LANDMARK Sub-Study): 18% of patients who received PPI within 30 days of TAVI had ventricular pacing ≤1% at 1 year, with no significant difference among Myval, SAPIEN, and Evolut platforms. Atrial fibrillation was the strongest negative predictor (OR 0.09). Read the study →
- CMR-Derived LACI Predicts CV Mortality Post-TAVR: In 138 patients with severe AS, a left atrioventricular coupling index ≥44.1% was independently associated with cardiovascular death over 2.7 years of follow-up (HR 2.19 after adjustment). Published in European Heart Journal — Imaging Methods and Practice. Read the study →
- Late Mitral Stenosis After TEER from Connective Tissue Disease: A case report documenting progressive MS following transcatheter edge-to-edge repair in a patient with mixed connective tissue disease — a reminder that leaflet pathology can evolve post-procedure. Read the case →
- Tricuspid Valve Interventions: The EP Perspective: A comprehensive review synthesizes conduction system risks across both surgical and transcatheter tricuspid approaches, advocating for electrophysiologist integration into the heart team. Read the review →
Aortic Valve (TAVR/TAVI)
Pacemaker Recovery After TAVI: The LANDMARK Sub-Study
[NOTABLE] This post-hoc analysis from the LANDMARK multicenter trial tackles one of the most vexing complications in TAVR: permanent pacemaker implantation. Among 768 patients randomized 2:1:1 to Myval, SAPIEN, and Evolut series, 122 (15.9%) received PPI within 30 days. Of the 99 with available 1-year pacemaker follow-up, 18 (18%) demonstrated conduction recovery, defined as ventricular pacing ≤1%.
The key finding: recovery rates did not differ significantly by valve platform (Myval 25%, SAPIEN 19%, Evolut 7%; p=0.16), though the numerically lower Evolut rate is worth noting given the well-documented higher PPI rates with self-expanding platforms. Implantation depth under the non-coronary cusp was identical between recovery and non-recovery groups (5.7 vs 5.8 mm), suggesting that depth alone doesn't predict reversibility. The most powerful predictor was atrial fibrillation, which was associated with a 91% lower odds of recovery (OR 0.09, p=0.02).
Editorial perspective: These data reinforce what several groups have previously reported — that a meaningful minority of TAVI patients are pacemaker-dependent unnecessarily, and that our threshold for PPI may be too low. The 2025 ESC guidelines already recommend a period of monitoring (ideally with temporary pacing and ambulatory ECG) before committing to permanent implantation, but real-world practice varies enormously. The AF finding is mechanistically intuitive (AF reflects more advanced conduction system disease) but clinically actionable: it suggests that watchful waiting for recovery may be most productive in sinus rhythm patients. The 7% Evolut recovery rate, while not statistically different, deserves scrutiny in larger datasets — if confirmed, it would further distinguish the conduction profiles of balloon- vs self-expanding platforms. Limitations include the post-hoc design, retrospective pacemaker data collection, and the modest sample size (n=99), which limits multivariable modeling.
CMR-Derived LACI for Pre-TAVR Risk Stratification
A prospective single-center study from Göttingen in European Heart Journal — Imaging Methods and Practice introduces the left atrioventricular coupling index (LACI), defined as the ratio of left atrial to left ventricular end-diastolic volume indices on CMR, as a prognostic marker in severe AS. Among 138 consecutive TAVR candidates (median age 80, 62% male), patients with high LACI (≥44.1%) had greater symptom burden, more AF, and higher NT-proBNP. Over 2.7 years of follow-up, high LACI was independently associated with cardiovascular mortality (HR 2.19 after adjustment for LA reservoir strain; HR 2.21 after adjustment for LV GLS).
Editorial perspective: The concept is appealing — LACI captures the structural footprint of advanced atrioventricular remodeling in a single, easily derived CMR metric. However, this is a small, single-center study with only 138 patients and an unspecified number of events, making the multivariable adjustments exploratory at best. The clinical question is whether LACI adds incrementally to existing risk tools (STS-PROM, EuroSCORE II) for TAVR decision-making. Validation in multicenter cohorts is needed before this enters clinical workflows.
Pulse Wave Velocity and Ventricular-Vascular Coupling After TAVR
A retrospective study of 100 elderly TAVR patients examined estimated pulse wave velocity (ePWV) as a surrogate for arterial load. TAVR produced a modest reduction in ePWV (12.79 to 12.39 m/s, p<0.01) and a small LVEF improvement (44.9% to 46.7%, p<0.01) at discharge. Higher baseline ePWV correlated with adverse LV remodeling. While the concept of ventricular-vascular coupling in AS is important, the authors themselves caution that ePWV is directly blood-pressure-dependent, limiting its interpretive value in the acute post-procedural setting.
Alpha-Gal Syndrome and Bioprosthetic TAVR
A case report in Case Reports in Immunology describes successful TAVR with a bovine-derived bioprosthesis in an 84-year-old woman with serologically confirmed alpha-gal syndrome (specific alpha-gal IgE >100 kU/L). Pre-treatment with cetirizine, omalizumab, and prednisone 60mg prevented any hypersensitivity reaction; perioperative tryptase remained normal. While reassuring, this single case hardly constitutes a protocol — standardized perioperative management guidelines for AGS patients requiring bioprosthetic implants remain an unmet need, particularly as tick-borne AGS prevalence increases in the southeastern US.
Neurological Dysfunction After TAVR
A new publication in the Journal of Cardiothoracic Surgery examines risk factors for neurological dysfunction after TAVR. No abstract is currently available; we will update when full text is accessible. Stroke and neurocognitive decline remain among the most feared TAVR complications, with cerebral embolic protection device utilization still debated.
Emergency PCI and TAVR for AMI with Severe AS
A case report explores the challenging scenario of acute myocardial infarction presenting in a patient with severe aortic stenosis and cardiogenic shock, treated with combined emergency PCI and TAVR. Acute MI is traditionally a contraindication to TAVR; this case adds to a small but growing literature on emergent combined approaches in extremis. These reports are hypothesis-generating at best and should not shift practice without prospective data.
Mitral Valve (MitraClip, PASCAL, TMVR)
Late Mitral Stenosis Post-TEER in Connective Tissue Disease
A case report in the Canadian Journal of Cardiology documents late-onset mitral stenosis following transcatheter edge-to-edge repair in a patient with mixed connective tissue disease (MCTD). While the full text is not yet available, this case raises an important concern: connective tissue disorders may predispose to progressive leaflet thickening and stenosis after TEER, as the inflammatory and fibrotic milieu can accelerate tissue bridging across clip sites. This mirrors known concerns about TEER in rheumatic MR, where ongoing leaflet pathology undermines procedural durability.
Editorial note: The COAPT and MITRA-FR trials excluded patients with active autoimmune conditions, and both the ACC/AHA and ESC guidelines assume relatively stable leaflet tissue when recommending TEER. Cases like this underscore that patient selection must account for underlying leaflet biology, not just anatomy.
Tricuspid Valve (TriClip, TTVR)
Tricuspid Valve Interventions: An Electrophysiology-Focused Review
A comprehensive review in the Journal of Cardiovascular Development and Disease examines the conduction system implications of both surgical and transcatheter tricuspid valve interventions. The review highlights the intimate anatomic relationship between the tricuspid annulus and the AV conduction axis — a relationship that makes conduction disturbances a near-universal concern across all TR treatment modalities.
Key themes include: the mechanisms underlying procedure-related conduction abnormalities (direct compression, suture injury, device impingement on the AV node or bundle of His); management of pre-existing transvenous leads during transcatheter TV procedures; valve-sparing pacing alternatives; and the evolving role of electrophysiologists as core members of the tricuspid heart team.
Editorial perspective: This review arrives at a critical moment. The 2025 ESC guidelines now recommend transcatheter TV treatment at Class IIa for symptomatic severe TR, and real-world STS/ACC TVT Registry data show a 15.9% new CIED implantation rate after TTVR. The tricuspid space is rapidly expanding, but the conduction system implications have received less attention than they deserve. As with TAVR a decade ago, conduction disturbances may become the Achilles' heel of transcatheter tricuspid therapies if not proactively addressed through device design, procedural technique, and EP collaboration.
Device & Technology
Anteris Technologies Advances DurAVR US Pivotal Trial
According to Kalkine Media, Anteris Technologies (ASX: AVR) is advancing its DurAVR transcatheter heart valve system in its US pivotal clinical trial (NCT07194265, enrolling 1,650 patients). The DurAVR is a single-piece valve designed with ADAPT anti-calcification tissue technology, aiming to address durability concerns that continue to shadow conventional THV platforms. The trial is comparing DurAVR against the SAPIEN and Evolut series — directly taking on the two dominant platforms. This is an ambitious play from a company with a $700M market cap competing against Edwards ($48B) and Medtronic ($107B).
Sahajanand Medical Technologies (Meril) Hydra THV Registries
Three Hydra THV registry updates appeared today. The Meril Hydra system — manufactured by Indian-based Sahajanand Medical Technologies — continues expanding its real-world evidence base across multiple geographies:
- Copenhagen single-center experience (NCT06342635): Recruiting, n=50
- Italy Registry (NCT05956652): Recruiting, n=500
- UK Registry (NCT06507579): Recruiting, n=250
Meril remains a private company, but its Hydra platform represents the most significant emerging-market TAVR competitor. These registries will be important for establishing a safety and efficacy profile outside the resource-rich trial environments of the major pivotal studies.
Industry & Market
Edwards Lifesciences at BofA Health Care Conference
Edwards Lifesciences announced it will present at the Bank of America Securities 2026 Health Care Conference — a key investor event where management typically provides updated guidance on TAVR volumes, PASCAL uptake, and EVOQUE tricuspid replacement trajectory. Watch for commentary on the 2025 ESC guideline impact on European TAVI volumes and any updates on the CLASP II TR and TRISCEND II long-term data.
Institutional Activity in Edwards Lifesciences
MarketBeat reports that AMG National Trust Bank has taken a new position in Edwards Lifesciences, joining a wave of institutional activity around the structural heart leader.
TAVI Access Expansion in India
The Hindu reports that KLE's Hospital and MRC (KHPIMS) in Gadag, India, performed free TAVI procedures — highlighting the growing push for TAVR access in lower-resource settings. India remains one of the largest potential TAVR markets globally, with an enormous burden of rheumatic and degenerative valve disease, though bicuspid morphology and rheumatic etiology complicate direct application of Western RCT evidence.
Tirzepatide and Structural Heart Procedures
Cardiovascular Business reports on emerging data suggesting tirzepatide (GLP-1/GIP receptor agonist) may benefit patients undergoing TAVR and PCI — a reminder that the metabolic-cardiovascular interface is increasingly relevant to structural heart outcomes. Weight optimization before TAVR can improve vascular access, reduce anesthetic risk, and potentially improve long-term outcomes, though prospective data are needed.
Financial Analysis
The structural heart sector continues to trade in a challenging macro environment, with broad medtech weakness pulling several names toward 52-week lows. The divergence between Edwards Lifesciences and the rest of the field is striking: Edwards has essentially flat-lined over six months (+1.6%), while Abbott (-25.9%), Boston Scientific (-40.6%), and Medtronic (-9.7%) have experienced significant declines. This likely reflects Edwards' pure-play structural heart positioning providing some insulation, while the diversified players face headwinds across their broader portfolios.
Edwards' upcoming BofA Securities Health Care Conference presentation will be closely watched for updated TAVR volume guidance in the context of the 2025 ESC guidelines, which effectively expanded the TAVI-eligible population by lowering the age threshold to 70. European volume acceleration could be a meaningful catalyst. Meanwhile, Edwards' EVOQUE tricuspid replacement and PASCAL mitral/tricuspid platforms represent the next growth vectors, with both TRISCEND II and CLASP II TR in late-stage enrollment.
Medtronic, approaching its June 3 earnings report, will need to address its cardiovascular segment trajectory including Evolut FX momentum and the Intrepid TMVR pivotal trial progress. Boston Scientific's 40% six-month decline is dramatic, though its structural heart exposure (via ACURATE neo2 TAVI) is modest relative to its broader business. Anteris Technologies, the DurAVR developer, remains a speculative small-cap ($700M market cap) with no revenue, but its US pivotal trial enrollment represents a binary event for the stock.
Valve Industry Stocks
Edwards Lifesciences (EW)
- Close: $83.46 | Daily Change: -$0.69 (-0.82%)
- 6-Month Performance: +$1.27 (+1.55%)
- Market Cap: $48.1B | P/E (trailing): 46.11 | P/E (forward): 24.84
- Beta: 0.94 | 52-Week Range: $72.30 - $87.89
- Analyst Consensus: Buy | Target: $96.96 (range $84 - $110, 27 analysts)
- Next Earnings: July 23, 2026 | EPS est: $0.74 | Rev est: $1.70B
- Commentary: Edwards remains the structural heart bellwether, trading near the top of its 52-week range despite a rich trailing P/E. The forward P/E of 24.8 reflects expected earnings growth from TAVR volume expansion (especially in Europe post-ESC guidelines), PASCAL TEER adoption, and EVOQUE TR replacement. The BofA conference presentation this week may serve as a catalyst. Institutional buying (AMG National Trust) signals continued confidence. Key risks: TAVR pricing pressure, competitive threats from Meril and Anteris, and the ongoing durability debate limiting expansion below age 70.
Medtronic (MDT)
- Close: $82.92 | Daily Change: -$0.40 (-0.48%)
- 6-Month Performance: -$8.88 (-9.67%)
- Market Cap: $106.5B | P/E (trailing): 23.16 | P/E (forward): 13.69
- Beta: 0.76 | 52-Week Range: $79.93 - $106.33
- 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, down nearly 10% over six months despite a relatively attractive forward P/E of 13.7. The structural heart segment (Evolut FX, Intrepid TMVR) is a growth engine, but it is diluted within Medtronic's massive diversified portfolio. The LANDMARK sub-study showing 7% pacemaker recovery with Evolut (lowest among THV platforms, though not statistically significant) may draw attention ahead of the upcoming earnings call. The Intrepid TMVR pivotal trial (n=1,056, recruiting) remains a key long-term value driver.
Abbott (ABT)
- Close: $92.80 | Daily Change: +$1.67 (+1.83%)
- 6-Month Performance: -$32.39 (-25.87%)
- Market Cap: $161.3B | P/E (trailing): 25.99 | P/E (forward): 15.30
- 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
- Commentary: Abbott's 26% six-month decline is striking for a company with dominant positions in both MitraClip/TriClip (TEER) and structural heart diagnostics. The stock is trading at its 52-week low. While non-structural heart headwinds (nutrition, diagnostics litigation) explain much of the pressure, investors will be watching TRILUMINATE Pivotal long-term data and REPAIR-MR outcomes closely. The MitraClip G5 registry (NCT07543874, 1,000 patients planned at University Hospital Cologne) signals continued platform evolution.
Boston Scientific (BSX)
- Close: $59.95 | Daily Change: -$2.12 (-3.42%)
- 6-Month Performance: -$41.02 (-40.63%)
- Market Cap: $89.1B | P/E (trailing): 25.08 | P/E (forward): 15.90
- Beta: 0.78 | 52-Week Range: $59.39 - $109.50
- Analyst Consensus: Strong Buy | Target: $85.91 (range $69 - $110, 32 analysts)
- Next Earnings: July 22, 2026 | EPS est: $0.83 | Rev est: $5.40B
- Commentary: Boston Scientific has been brutalized, losing over 40% in six months and hitting fresh 52-week lows. The strong buy consensus (32 analysts, target $85.91 representing 43% upside) suggests Wall Street views this as overdone. BSX's structural heart footprint is modest compared to Edwards and Abbott, centered primarily on its ACURATE neo2 TAVI platform and emerging WATCHMAN FLX (left atrial appendage closure, adjacent to the structural heart space). The sharp discount may attract value investors, but macro headwinds persist.
Anteris Technologies (AVR.AX)
- Close: A$7.55 | Daily Change: -A$0.05 (-0.66%)
- 6-Month Performance: -A$0.94 (-11.07%)
- Market Cap: A$700M | P/E (forward): -3.46 (pre-revenue)
- Beta: 0.55 | 52-Week Range: A$4.68 - A$9.79
- Analyst Target: A$13.00 (1 analyst)
- Commentary: Anteris is the pure-play disruptor in the TAVR space with its DurAVR single-piece THV featuring ADAPT anti-calcification tissue technology. The ongoing US pivotal trial (NCT07194265, n=1,650, recruiting, comparing against SAPIEN and Evolut) is the central catalyst. As a pre-revenue company with a negative forward P/E, this remains a high-risk/high-reward play predicated entirely on the DurAVR's ability to demonstrate superior durability. Kalkine Media coverage today highlighted the US trial advancement.
Private Companies of Note: JenaValve Technology (aortic regurgitation TAVR — the JenaValve Trilogy system), J Valve Technology, and Meril Life Sciences (Hydra THV, Myval) remain private and do not have publicly traded equity. Meril's Hydra registries across Denmark, Italy, and the UK continue expanding, positioning the company for potential regulatory approvals and commercial expansion in Europe.
Market Outlook: The structural heart sector faces a paradox: clinical evidence and guideline expansions are at their strongest ever (ESC 2025 upgraded TEER for SMR to Class I, lowered TAVI age threshold to 70, and endorsed transcatheter TR therapy at IIa), yet stock performance across the sector is weak. This reflects broader medtech/macro headwinds rather than structural heart-specific concerns. For investors, the dislocation between strengthening clinical fundamentals and compressed valuations may present an opportunity — but tariff risks, reimbursement uncertainty, and the ever-present question of TAVR durability in younger patients remain overhangs.
Clinical Trial Updates
Aortic Valve Trials
- NCT06342635 — Hydra Single-Centre Experience (Copenhagen)
- Status: Recruiting | Phase: N/A | Enrollment: 50
- Sponsor: Sahajanand Medical Technologies (Meril)
- Intervention: Hydra THV Series
- ClinicalTrials.gov →
- NCT05956652 — Hydra Registry (Italy)
- Status: Recruiting | Phase: N/A | Enrollment: 500
- Sponsor: Sahajanand Medical Technologies
- Intervention: Hydra Transcatheter Aortic Valve System
- ClinicalTrials.gov →
- NCT06507579 — Hydra Registry (UK)
- Status: Recruiting | Phase: N/A | Enrollment: 250
- Sponsor: Sahajanand Medical Technologies
- Intervention: Hydra THV Series
- ClinicalTrials.gov →
- NCT07194265 — DurAVR THV System Pivotal Trial
- Status: Recruiting | Phase: N/A | Enrollment: 1,650
- Sponsor: Anteris Technologies
- Intervention: DurAVR THV vs SAPIEN/Evolut series
- Significance: Head-to-head RCT against incumbent platforms; key test of ADAPT anti-calcification technology
- ClinicalTrials.gov →
- NCT07545369 — ULTRA-EVOLUT RCT (SAPIEN 3 Ultra Resilia vs Evolut FX)
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 200
- Sponsor: Assiut University
- Significance: Latest-generation head-to-head comparison between the two dominant TAVR platforms
- ClinicalTrials.gov →
- NCT07539909 — Alternative Peripheral TAVI Accesses
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 600
- Sponsor: Medical University of Silesia
- ClinicalTrials.gov →
- NCT06638268 — TAVI in Aortic Stenosis Cardiogenic Shock (TACTICS)
- Status: Recruiting | Phase: N/A | Enrollment: 30
- Sponsor: Rigshospitalet, Denmark
- Intervention: Acute TAVI vs stabilization + subacute TAVI
- ClinicalTrials.gov →
- NCT07317804 — ECHO-TAVR (Echo-Guided vs Fluoroscopy-Guided TAVR)
- Status: Not Yet Recruiting | Phase: Phase 4 | Enrollment: 212
- Sponsor: China National Center for Cardiovascular Diseases
- ClinicalTrials.gov →
- NCT04443023 — Comparison of Eligible TAVI Valves (Cohort B)
- Status: Completed | Phase: N/A | Enrollment: 1,031
- Sponsor: Aarhus University Hospital
- ClinicalTrials.gov →
- NCT06171802 — EMPagliflozin After Aortic Valve Replacement
- Status: Active, Not Recruiting | Phase: Phase 4 | Enrollment: 205
- Sponsor: Rigshospitalet, Denmark
- Significance: Testing SGLT2 inhibitor benefit in post-AVR reverse remodeling
- ClinicalTrials.gov →
- NCT05145283 — C1 Esterase Inhibitor for Cerebral/Renal Protection After TAVI
- Status: Completed | Phase: Phase 2 | Enrollment: 141
- Sponsor: University Hospital Basel
- ClinicalTrials.gov →
- NCT06412354 — EasyCross Self-Centering Catheter (First-in-Human)
- Status: Completed | Phase: N/A | Enrollment: 20
- Sponsor: Vivheart s.r.l.
- ClinicalTrials.gov →
- NCT06857201 — RAFT-TAVR PACE (LBBAP vs RVP Post-TAVR)
- Status: Withdrawn | Phase: N/A | Enrollment: 0
- Sponsor: Lawson Research Institute
- Note: This trial comparing left bundle branch area pacing to right ventricular pacing after TAVR was withdrawn before enrollment. The question it aimed to address — whether conduction system pacing is superior to RV pacing in post-TAVR PPI patients — remains important and unanswered.
- ClinicalTrials.gov →
- [LANDMARK] NCT02701283 — Evolut Low Risk (Long-Term Follow-Up)
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 2,223
- Sponsor: Medtronic Cardiovascular
- Significance: Providing the extended follow-up data (now approaching 7+ years) that are critical for validating TAVR durability in low-risk patients. Along with PARTNER 3, this trial underpins the ESC's decision to set the TAVI-preferred threshold at age 70 for tricuspid aortic valves.
- ClinicalTrials.gov →
- NCT07511673 — Preoperative Dental Screening Before Valve Surgery/TAVI
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 1,300
- Sponsor: Region Skane (Sweden)
- Significance: A pragmatic RCT testing whether dental screening reduces endocarditis and infection after valve procedures — an understudied but clinically important question.
- ClinicalTrials.gov →
Mitral Valve — Repair Trials
- NCT07543874 — MitraClip Generation 5 Registry
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 1,000
- Sponsor: University Hospital of Cologne
- Intervention: MitraClip G5
- Significance: First large-scale registry for the next-generation MitraClip platform; will provide real-world performance data.
- ClinicalTrials.gov →
- NCT07086534 — GeminiOne TEER System (First-in-Human)
- Status: Recruiting | Phase: N/A | Enrollment: 15
- Sponsor: Sierra Valve LLC
- Intervention: GeminiOne TEER system for severe symptomatic MR
- ClinicalTrials.gov →
- [LANDMARK] NCT04198870 — REPAIR-MR (MitraClip vs Surgery for Primary MR)
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 500
- Sponsor: Abbott Medical Devices
- Significance: The definitive head-to-head RCT comparing TEER (MitraClip) vs surgical MV repair for primary MR. Results will determine whether TEER can compete with surgery — the current gold standard — in the primary MR population. Both ACC/AHA and ESC currently recommend surgery as first-line (Class I) for primary MR, with TEER only at IIa for high-risk patients.
- ClinicalTrials.gov →
- [LANDMARK] NCT05051033 — PRIMATY (TEER vs Medical Therapy for Secondary MR)
- Status: Recruiting | Phase: N/A | Enrollment: 450
- Sponsor: Annetine Gelijns
- Significance: An independent, investigator-initiated trial comparing MV repair (surgical and transcatheter) vs medical therapy for secondary MR — designed to resolve remaining questions from COAPT/MITRA-FR about patient selection and generalizability.
- ClinicalTrials.gov →
- [LANDMARK] NCT03706833 — COAPT (Long-Term Follow-Up, Now PASCAL Arm)
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 1,247
- Sponsor: Edwards Lifesciences
- Significance: The trial that established TEER for ventricular SMR. Now includes a PASCAL system arm (Edwards) alongside the original MitraClip (Abbott) data. Long-term follow-up continues to be watched for durability and sustained mortality/HF hospitalization benefit. The ESC 2025 upgrade of TEER for SMR to Class I was driven largely by COAPT 5-year data.
- ClinicalTrials.gov →
Mitral Valve — Replacement Trials
- [LANDMARK] NCT03242642 — Intrepid TMVR Pivotal
- Status: Recruiting | Phase: N/A | Enrollment: 1,056
- Sponsor: Medtronic Cardiovascular
- Significance: The largest ongoing TMVR pivotal trial. TMVR remains a frontier therapy — no device has yet achieved full FDA approval for transcatheter mitral valve replacement. The Intrepid system targets patients who are not candidates for surgical MV repair/replacement or TEER.
- ClinicalTrials.gov →
Tricuspid Valve — Repair Trials
- [LANDMARK] NCT03904147 — TRILUMINATE Pivotal (TriClip for TR)
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 572
- Sponsor: Abbott Medical Devices
- Significance: The pivotal trial that established transcatheter TR TEER. Along with Tri.Fr, TRILUMINATE was a primary basis for the ESC 2025 Class IIa recommendation for transcatheter TV treatment. Extended follow-up data will be critical for durability assessment.
- ClinicalTrials.gov →
- [LANDMARK] NCT04097145 — CLASP II TR (PASCAL for TR)
- Status: Recruiting | Phase: N/A | Enrollment: 870
- Sponsor: Edwards Lifesciences
- Significance: Edwards' PASCAL system pivotal trial for tricuspid TEER, competing directly with Abbott's TriClip. Enrollment of 870 makes this one of the largest TR device trials.
- ClinicalTrials.gov →
Tricuspid Valve — Replacement Trials
- [LANDMARK] NCT04482062 — TRISCEND II (Evoque Tricuspid Replacement)
- Status: Active, Not Recruiting | Phase: N/A | Enrollment: 864
- Sponsor: Edwards Lifesciences
- Significance: The pivotal RCT comparing the EVOQUE transcatheter TV replacement system vs optimal medical therapy. TRISCEND II showed superiority for symptoms/QoL but flagged higher bleeding and pacemaker rates — a tradeoff that will determine the ultimate role of TTVR vs TEER in the tricuspid space.
- ClinicalTrials.gov →
Other Relevant Trials
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction
- Status: Not Yet Recruiting | Phase: N/A | Enrollment: 1,000
- Sponsor: NHLBI
- Relevance: Advanced CT reconstruction for structural heart planning
- ClinicalTrials.gov →
- NCT06655480 — Triple Combination Therapy in Advanced HFpEF
- Status: Recruiting | Phase: Phase 2 | Enrollment: 50
- Sponsor: National Medical Research Center for Cardiology (Russia)
- Relevance: HFpEF therapy optimization; relevant to secondary TR and atrial functional MR populations
- ClinicalTrials.gov →
- NCT03152773 — MRI-Guided Heart Catheterization
- Status: Suspended | Phase: N/A | Enrollment: 22
- Sponsor: NHLBI
- ClinicalTrials.gov →
Social & Conference Highlights
Edwards Lifesciences will present at the BofA Securities 2026 Health Care Conference — expect updated guidance on TAVR volumes, PASCAL/EVOQUE commercial trajectories, and the impact of ESC 2025 guidelines on European market dynamics. This is typically one of the most closely watched investor events for the structural heart sector.
The passing of a figure described by Cardiovascular Business as the "father of modern cardiology" at age 96 was noted in today's news cycle. We will provide attribution and context when the full obituary is available.
Looking Ahead: The LANDMARK pacemaker recovery data should prompt a broader discussion about post-TAVI PPI decision-making — are we implanting devices too quickly, and should AF status factor into the waiting period? With Medtronic earnings on June 3 and Edwards at BofA this week, the next month will provide important visibility on how guideline expansions are translating into real-world procedure volumes. Tomorrow we'll be watching for any new publications from the TRILUMINATE and TRISCEND II extended follow-up, and for updates from the GeminiOne first-in-human TEER study.
— E. Nolan Beckett | The Valve Wire