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THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
NCT02732704 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02732704
The ClinicalTrials.gov registry entry for NCT02732704 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JenaValve Technology, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02732704 reports 19 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02732704?
The interventions under investigation include: JenaValve Pericardial TAVR System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02732704?
This trial is sponsored by JenaValve Technology, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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