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Clinical Trials in the USA / NCT02732704
Active, not recruiting Not applicable

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

NCT02732704 · tracked via the Priya Life Science USA tracker
Sponsor
JenaValve Technology, Inc
Phase
Not applicable
Started
2018-04-20
Last updated
2022-11-18

Condition(s) studied

Aortic Regurgitation

Investigational drug(s) / intervention(s)

JenaValve Pericardial TAVR System

JenaValve Pericardial TAVR System: TAVR with JenaValve Pericardial Valve and Delivery System

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with severe aortic regurgitation (AR). * Patient at high risk for open surgical valve replacement * Patient symptomatic according to NYHA functional class II or higher * The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site. Exclusion Criteria: * Congenital uni or bicuspid aortic valve morphology * Previous prosthetic aortic valve (bioprosthesis or mechanical) implant * Endocarditis or other active infection * Need for urgent or emergent TAVR procedure for any reason * Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device * Severe mitral regurgitation

Primary outcome measure(s)

  • All-Cause Mortality at 30 days — 30 days
    All-Cause mortality within the first 30 days post index procedure

Trial sites (19)

FacilityCityRegionStatus
Cedars Sinai Medical Center Los Angeles California
California Pacific Medical Center Research Institute San Francisco California
MedStar Washington Hospital Center Washington D.C. District of Columbia
Piedmont Healthcare Atlanta Georgia
Emory University Hospital Atlanta Georgia
University of Michigan Ann Arbor Michigan
New York-Presbyterian/ Columbia University Medical Center New York New York
Baylor Scott & White Research Institute Dallas Texas
University of Washington Seattle Washington
Kerckhoff-Klinik GmbH Bad Nauheim Bad Nauheim Germany
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen Bad Oeynhausen Germany
Deutsches Herzzentrum Berlin Berlin Germany
Universitätsklinikum Bonn Bonn Germany
Herzzentrum der Universität zu Köln Cologne Germany
Universitätsklinikum Frankfurt Frankfurt Germany
Universitäres Herzzentrum Hamburg Hamburg Germany
Leiden University Medical Center Leiden Netherlands
St. Antonius Hospital Nieuwegein Netherlands
Erasmus University Medical Center Rotterdam Netherlands

More JenaValve Technology, Inc. trials in the USA

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ Recruiting
The JenaValve ALIGN-AR LVAD Registry Active, not recruiting
The JenaValve ALIGN-AR Pivotal Trial Active, not recruiting

Other trials for the same condition

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ Recruiting
J-Valve TF Early Feasibility Study Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry Active, not recruiting
The JenaValve ALIGN-AR Pivotal Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02732704 on ClinicalTrials.gov ↗ ← All trials in the USA