JenaValve ALIGN-AR registry for treating aortic regurgitation in patients with continuous-flow LVADs.

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)

This will test the JenaValve Trilogy heart valve as a less-invasive way to fix significant aortic regurgitation in adults who have continuous-flow LVADs and are high risk for open-heart surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: JenaValve Technology, Inc. (industry)
• Locations: 15 sites (Los Angeles, California and 14 other locations)
• Trial ID: NCT06594705 on ClinicalTrials.gov

What this trial studies

This interventional, multicenter registry enrolls adults with continuous-flow left ventricular assist devices (cfLVAD) who have clinically significant aortic regurgitation and are high risk for surgical aortic valve replacement. Eligible participants must have AR graded ≥3, NYHA class III/IV symptoms, and anatomy suitable for transcatheter aortic valve replacement with the JenaValve Trilogy system. The procedure involves transcatheter implantation of the JenaValve Trilogy and standardized post-procedure follow-up to monitor device performance, AR reduction, LVAD function, and safety outcomes. Data will be collected across participating U.S. centers to characterize procedural success, adverse events, and clinical course after implantation.

Who should consider this trial

Good fit: Adults (≥18) with a continuous-flow LVAD, clinically significant AR (grade ≥3), NYHA class III/IV, judged high risk for surgical valve replacement by a Heart Team, and with anatomy suitable for the device are ideal candidates.

Not a fit: Patients with only mild or trace AR, unsuitable aortic anatomy for the device, low surgical risk for conventional valve surgery, or other contraindications to transcatheter valve placement are unlikely to benefit.

Why it matters

Potential benefit: If successful, the procedure could reduce aortic regurgitation, improve LVAD function and symptoms, and offer a treatment option without open-heart surgery.

How similar studies have performed: TAVR for AR in LVAD patients is an emerging approach supported mainly by small case series and registries showing feasibility but lacks large-scale controlled evidence to confirm broad effectiveness.

Eligibility criteria

Inclusion Criteria:

1. Subjects \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:

   • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1
2. Patient with NYHA functional class III/IV
3. Patient with high risk for SAVR as documented by Heart Team.
4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
5. Patient or the patient's legal representative has provided written informed consent
6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits

Exclusion Criteria:

1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
3. Mitral regurgitation \> moderate
4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure
5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
7. Hypertrophic cardiomyopathy with or without obstruction
8. Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)
9. Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure \> pulmonary capillary wedge pressure and cardiac index \< 2.5 L/min/m2
10. Severe RV dysfunction as assessed clinically and by echocardiography
11. Aortic annular diameter of \<21.0 mm or \> 28.6 mm (assessed by Multi-detector CT measurement)
12. Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement)
13. Straight length of ascending aorta of \< 55 mm
14. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\>5 mm\], protruding or ulcerated)
15. Myocardial infarction \< 30 days prior to index procedure
16. Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure
17. Blood dyscrasias as defined: leukopenia (WBC \< 3000/mm³), or thrombocytopenia (platelets \< 90,000/μl) or anemia (Men: Hgb \< 8.1 g/dl; Women: Hgb \< 7.4 g/dl)
18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure
19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)

Where this trial is running

Los Angeles, California and 14 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
• Sutter Health — San Francisco, California, United States (RECRUITING)
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
• Emory University — Atlanta, Georgia, United States (RECRUITING)
• Piedmont — Atlanta, Georgia, United States (RECRUITING)
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States (RECRUITING)
• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
• Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (RECRUITING)
• Washington University, St. Louis — St Louis, Missouri, United States (RECRUITING)
• Columbia University Medical Center/New York-Presbyterian Hospital — New York, New York, United States (RECRUITING)
• Houston Methodist Research Center — Houston, Texas, United States (RECRUITING)
• Baylor — Plano, Texas, United States (RECRUITING)
• Intermountain — Murray, Utah, United States (RECRUITING)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Vinod Thourani, MD — Piedmont Heart Institute
• Study coordinator: David Haan

Conditions: Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease, Left Ventricular Dysfunction