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NCT02732704 · ClinicalTrials.gov record · last posted 2022-11-18

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

StatusActive, Not Recruiting
PhaseNot applicable
Started2018-04-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 10 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 10 times since 2016-04-08; most recent amendment 2022-11-16. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2021-07-30
Status change Recruiting→Active, Not Recruitingv9
2020-03-05
Status change Enrolling by Invitation→Recruitingv5
2018-11-06
Status change Active, Not Recruiting→Enrolling by Invitationv3
2017-06-16
Status change Not Yet Recruiting→Active, Not Recruitingv2
2016-05-02
Status change Withheld→Not Yet Recruitingv1
Trial Details
NCT Number NCT02732704
Lead Sponsor JenaValve Technology, Inc.
Conditions Aortic Regurgitation
Enrollment 100 participants
Start Date 2018-04-20
Primary Completion 2022-08-29 (estimated)
Study Completion 2027-09-29 (estimated)
Updated on ClinicalTrials.gov 2022-11-18