THE ALIGN-AR PIVOTAL TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
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- STATUS
- Recruiting
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- End date
- Dec 5, 2025
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- participants needed
- 50
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- sponsor
- JenaValve Technology, Inc.
Summary
To collect information about treatment for symptomatic 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.
Description
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
Details
| Condition | Aortic Regurgitation, VALVULAR HEART DISEASE, Aortic Valve Disease |
|---|---|
| Age | 18-100 years |
| Treatment | JenaValve Pericardial TAVR System |
| Clinical Study Identifier | NCT04415047 |
| Sponsor | JenaValve Technology, Inc. |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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