Investigational Valve System for Severe Aortic Regurgitation

Trial ID:
Curtiss Stinis, MD
This study will assess the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation (AR). Expected study duration: 72 months
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