| NCT ID | NCT06594705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JenaValve Technology, Inc. |
| Condition | Aortic Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-12-09 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Eligibility Criteria
Inclusion Criteria: 1. Subjects \&gt;=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 \&gt; 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 \&gt;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)
Contact & Investigator
Nir Uriel, MD
STUDY CHAIR
Columbia University
Frequently Asked Questions
Who can join the NCT06594705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06594705 currently recruiting?
Yes, NCT06594705 is actively recruiting participants. Contact the research team at haan@jenavalve.com for enrollment information.
Where is the NCT06594705 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Washington D.C., United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT06594705 clinical trial?
NCT06594705 is sponsored by JenaValve Technology, Inc.. The principal investigator is Nir Uriel, MD at Columbia University. The trial plans to enroll 50 participants.