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Investigational Valve System for Severe Aortic Regurgitation

Trial ID:
IRB-22-7911
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
  • CRSLeadership@scrippshealth.org