The JenaValve ALIGN-AR Pivotal Trial

N/AActive Not RecruitingNCT04415047

JenaValve Technology, Inc.180 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Aortic Regurgitation Aortic Valve Insufficiency Aortic Insufficiency Aortic Valve Disease

Interventions

JenaValve Trilogy Heart Valve SystemDEVICE

TAVR with JenaValve Trilogy Heart Valve 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 (30)

Outcomes

Primary Outcomes

All-Cause Mortality at 1 Year

All-cause mortality within the first 12 months post index procedure

Time frame: 1 year

All Stroke

Number of patients that had a stroke

Time frame: 30 days

Major Bleeding

Number of patients that had any of these events

Time frame: 30 days

Acute Kidney Injury