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The JenaValve ALIGN-AR Pivotal Trial — ALIGN-AR  

Aortic Valve Disease Clinical Trial

Official title:
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04415047
Study type Interventional
Source JenaValve Technology, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date May 22, 2020
Completion date August 2028
View Details
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