Trials / Recruiting
RecruitingNCT06594705
The JenaValve ALIGN-AR LVAD Registry
Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- JenaValve Technology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Aortic Regurgitation
- Aortic Valve Insufficiency
- Aortic Insufficiency
- Aortic Valve Disease
- Left Ventricular Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | JenaValve Trilogy Heart Valve System | TAVR with JenaValve Trilogy Heart Valve System |
Timeline
- Start date
- 2024-12-09
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
- First posted
- 2024-09-19
- Last updated
- 2026-04-01
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06594705. Inclusion in this directory is not an endorsement.