RecruitingNot ApplicableNCT06594705

The JenaValve ALIGN-AR LVAD Registry

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)

Sponsor

JenaValve Technology, Inc.

Enrollment

50 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Disease Left Ventricular Dysfunction Aortic Valve Insufficiency Aortic Insufficiency aortic regurgitation

Summary

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called JenaValve Trilogy Heart Valve System for people with aortic insufficiency, aortic valve disease, and other related conditions. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEJenaValve Trilogy Heart Valve System

TAVR with JenaValve Trilogy Heart Valve System

Locations(15)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Sutter Health

San Francisco, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

Piedmont

Atlanta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Washington University, St. Louis

St Louis, Missouri, United States

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, United States

Houston Methodist Research Center

Houston, Texas, United States

Baylor

Plano, Texas, United States

Intermountain

Murray, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06594705

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