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NCT04415047 · ClinicalTrials.gov record · last posted 2022-09-13

The JenaValve ALIGN-AR Pivotal Trial

Study acronym: ALIGN-AR
StatusActive, Not Recruiting
PhaseNot applicable
Started2020-05-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 13, 2022 (before its estimated August 29, 2023 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Amendment record 11 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 11 times since 2020-05-31; most recent amendment 2026-03-31. 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 ↗

2022-09-07
Status change Recruiting→Active, Not Recruitingv8
2020-07-11
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT04415047
Lead Sponsor JenaValve Technology, Inc.
Conditions Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
Enrollment 180 participants
Start Date 2020-05-22
Primary Completion 2023-08-29 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2022-09-13