IRB Study Number 21-1167
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
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
Inclusion Criteria
- Adult subjects with severe AR as assessed by echocardiography^ based on ASE (American Society of Echocardiography) who meet various parameters
- Patient symptomatic according to NYHA functional class II or higher
- Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
- Additional inclusion criteria will be assessed by study staff
Exclusion Criteria
- Adult subjects with severe AR as assessed by echocardiography^ based on ASE (American Society of Echocardiography) who meet various parameters
- Patient symptomatic according to NYHA functional class II or higher
- Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
- Additional inclusion criteria will be assessed by study staff
