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NCT02732704 · ClinicalTrials.gov registry record · NA
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
A NA study of Aortic Regurgitation, sponsored by JenaValve Technology.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 19
- Study locations
NCT02732704: Active NA study of Aortic Regurgitation, sponsored by JenaValve Technology.
NCT02732704 is a NA study of Aortic Regurgitation that is active but no longer recruiting, run by JenaValve Technology. The registered enrollment target is 100 participants, below the 279-participant average among 6 other Aortic Regurgitation trials with a reported enrollment target (64% lower). The trial reports 19 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02732704, a NA study of Aortic Regurgitation, is active but no longer recruiting, sponsored by JenaValve Technology.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 19
- Study locations
Study Summary
To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Primary Outcome
All-Cause mortality within the first 30 days post index procedure
Conditions Studied
Interventions
- DEVICE JenaValve Pericardial TAVR System
Study Locations (19)
Other
- Kerckhoff-Klinik GmbH Bad Nauheim - Bad Nauheim
- Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen - Bad Oeynhausen
- Deutsches Herzzentrum Berlin - Berlin
- Universitätsklinikum Bonn - Bonn
- Herzzentrum der Universität zu Köln - Cologne
- Universitätsklinikum Frankfurt - Frankfurt
- Universitäres Herzzentrum Hamburg - Hamburg
- Leiden University Medical Center - Leiden
- St. Antonius Hospital - Nieuwegein
- Erasmus University Medical Center - Rotterdam
California
- Cedars Sinai Medical Center - Los Angeles
- California Pacific Medical Center Research Institute - San Francisco
Georgia
- Piedmont Healthcare - Atlanta
- Emory University Hospital - Atlanta
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Michigan
- University of Michigan - Ann Arbor
New York
- New York-Presbyterian/ Columbia University Medical Center - New York
Texas
- Baylor Scott & White Research Institute - Dallas
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-04-20 |
| Est. Completion | 2027-09-29 |
| Phase | NA |
What the registry record for NCT02732704 still lists
NCT02732704 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 279-participant average among 6 other Aortic Regurgitation trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Aortic Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which JenaValve Pericardial TAVR System is the first listed.
NCT02732704 lists 19 locations in 8 states (Other, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT02732704 about?
NCT02732704 is a clinical study titled "THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study". To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgita...
What is the current status of trial NCT02732704?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2018-04-20. Estimated completion is 2027-09-29.
What conditions does trial NCT02732704 study?
This clinical trial studies the following conditions: Aortic Regurgitation.
What interventions are being tested in trial NCT02732704?
The interventions under investigation include: JenaValve Pericardial TAVR System (DEVICE).
Who is sponsoring clinical trial NCT02732704?
This trial is sponsored by JenaValve Technology, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02732704 being conducted?
This trial has 19 study locations across California, District of Columbia, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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