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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06594705
The ClinicalTrials.gov registry entry for NCT06594705 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 18,614-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The listed sponsor is JenaValve Technology, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Related
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