JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

JenaValve Technology

Status

Active, not recruiting

Conditions

Ventricular Outflow Obstruction

Heart Valve Diseases

Aortic Valve Stenosis

Cardiovascular Diseases

Heart Diseases

Treatments

Device: JenaValve Pericardial TAVR System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02732691

CA-0001 EU (Other Identifier)

CA-0010 (Other Identifier)

P02C220_JV06EFS_CIP (Other Identifier)

CP-0003

CA-0001 Germany (Other Identifier)

Details and patient eligibility

About

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Full description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with severe degenerative native aortic stenosis (AS).
Patient at high risk for open surgical valve replacement
Patient symptomatic according to NYHA functional class II or higher

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