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NCT06594705 · ClinicalTrials.gov registry record · NA
The JenaValve ALIGN-AR LVAD Registry
A NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JenaValve Technology.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 14
- Study locations
NCT06594705: Recruiting NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JenaValve Technology.
NCT06594705 is a NA study of Aortic Valve Disease and Aortic Valve Insufficiency that is actively recruiting participants, run by JenaValve Technology. The registered enrollment target is 50 participants, below the 18,614-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06594705, a NA study of Aortic Valve Disease and Aortic Valve Insufficiency, is actively recruiting participants, sponsored by JenaValve Technology.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 14
- Study locations
Study 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
Primary Outcome
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
Conditions Studied
Interventions
- DEVICE JenaValve Trilogy Heart Valve System
Study Locations (14)
Georgia
- Emory University - Atlanta
- Piedmont - Atlanta
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Hospital - Detroit
Missouri
- Washington University in St. Louis - St Louis
- Washington University, St. Louis - St Louis
California
- Cedars-Sinai Medical Center - Los Angeles
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Illinois
- Advocate Christ Medical Center - Oak Lawn
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
New York
- Columbia University Medical Center/New York-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT06594705 shows while recruiting
NCT06594705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 18,614-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which JenaValve Trilogy Heart Valve System is the first listed.
NCT06594705 lists 14 locations in 11 states (Georgia, Michigan, Missouri).
Frequently Asked Questions
What is clinical trial NCT06594705 about?
NCT06594705 is a clinical study titled "The JenaValve ALIGN-AR LVAD Registry". 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
What is the current status of trial NCT06594705?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-12-09. Estimated completion is 2027-08.
What conditions does trial NCT06594705 study?
This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction, Aortic Regurgitation, Aortic Insufficiency.
What interventions are being tested in trial NCT06594705?
The interventions under investigation include: JenaValve Trilogy Heart Valve System (DEVICE).
Who is sponsoring clinical trial NCT06594705?
This trial is sponsored by JenaValve Technology, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06594705 being conducted?
This trial has 14 study locations across California, District of Columbia, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Valve Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06594705's enrollment target sits among peer trials
50 11th of 15 higher than 5 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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