Active, not recruitingNCT04415047

ALIGN-AR

Name: University of Washington Medical Center
Address: Seattle, WA

The JenaValve ALIGN-AR Pivotal Trial

JenaValve Technology, Inc.Multiple US sitesView on ClinicalTrials.gov

AI Description

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.

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Who can join: adult, older adult
Participants: 180
Expected completion: 2028-08
Funded by: industry

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What is being tested

DEVICE: JenaValve Trilogy Heart Valve System

What it measures

Acute Kidney Injury, Number of patients that had these events, 30 days
All Stroke, Number of patients that had a stroke, 30 days
All-Cause Mortality at 1 Year, All-cause mortality within the first 12 months post index procedure, 1 year
Major Bleeding, Number of patients that had any of these events, 30 days
Major Vascular Complications, Number of patients that had these events, 30 days
Permanent pacemaker implantation, Number of patients that had these events, 30 days
Surgery/intervention related to the device, Number of patients that had these events, 30 days
Total aortic regurgitation, Number of patients that had these events, 30 days