| 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 |
Trial Parameters
Eligibility Fast-Check
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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 \>=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 Exclusio