Investigational Valve System for Severe Aortic Regurgitation
- Trial ID:
- IRB-22-7911
- Curtiss Stinis, MD
Enrollment completion: Approx. 12 months. annual follow-up visits for 5 years.
Inclusion Criteria
Patients must:- Be 18 years or older with severe aortic regurgitation as assessed by echocardiography
- Be symptomatic according to NYHA functional class II or higher
- Be at high risk for surgical aortic valve replacement
- Meet all other eligibility criteria
Exclusion Criteria
Patients must not:- Have congenital aortic valve morphology
- Have a prosthetic aortic valve (bioprosthesis or mechanical) implant
- Have greater than moderate mitral regurgitation
- Have clinically significant coronary artery disease (CAD) that requires a revascularization procedure within 30 days before the study procedure, or a planned CAD revascularization procedure within 12 months after the study procedure
Additional Info
- JenaValve is an investigational system for transcatheter aortic valve implantation that differs from other commercially available systems. The JenaValve Pericardial TAVR System is designed to allow a controlled valve release and deployment during the entire implantation procedure under beating heart conditions.
Contact Info:
- Clinical Research Services
- CRSLeadership@scrippshealth.org