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

N/AActive Not RecruitingNCT02732704

JenaValve Technology, Inc.100 enrolled

Overview

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.

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 severe aortic regurgitation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Aortic Regurgitation

Interventions

JenaValve Pericardial TAVR SystemDEVICE

TAVR with JenaValve Pericardial Valve and Delivery System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Cedars Sinai Medical Center

Los Angeles, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

Outcomes

Primary Outcomes

All-Cause Mortality at 30 days

All-Cause mortality within the first 30 days post index procedure

Time frame: 30 days

Secondary Outcomes

Mortality

Absence of procedural mortality

Time frame: At 30 days

Peri-Procedural Myocardial Infarction

Peri-procedural and spontaneous myocardial infarction

Time frame: At ≤72hr after the index procedure

Stroke-Free Survival

Disabling or non-disabling stroke

Time frame: At 30 days and 1 year

Bleeding & Vascular Complications

Major and minor bleeding

Time frame: 30 days

Data from ClinicalTrials.gov

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