Clinical Trial Detail | Research

ALIGN/P02C320: 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) (ALIGN-AR PMA)

Purpose

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.

Inclusion Criteria

Ages Eligible for Study

18 Years and older (Adult, Older Adult )

Sexes Eligible for Study

All

Accepts Healthy Volunteers

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

NCT: NCT04415047

Stephen Bailey, MD

Thoracic and Cardiac Surgery

Allegheny General Hospital

Get Directions

Contact

For more information about this trial, please send an email to ClinicalTrials@ahn.org.

Connect with one of our specialists. We provide comprehensive, patient-centered care for a broad spectrum of conditions and treatments.

EXPLORE SERVICES