JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Cardiovascular Diseases Clinical Trial

Official title: JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases
• Constriction, Pathologic
• Heart Diseases
• Heart Valve Diseases
• Ventricular Outflow Obstruction

• NCT number: NCT02732691
• Study type: Interventional
• Source: JenaValve Technology, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2016
• Completion date: April 2024