IRB Study Number 25-1123
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study because you have been diagnosed with moderate-to-severe aortic (valve) regurgitation (AR). AR is a condition where the heart’s aortic valve (valve in the heart that controls blood flow from the left ventricle to the aorta) does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AR may include fatigue and shortness of breath. The typical treatment for AR is surgical aortic valve replacement (SAVR). The purpose of this study is to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation.
JenaValve Trilogy™ Transcatheter Heart Valve System is an investigational (experimental) device that works by replacing your aortic valve in a minimally invasive surgery known as a transcatheter aortic valve replacement (TAVR), instead of in an open-heart surgery such as the SAVR. It is not approved by the Food and Drug Administration (FDA).
Inclusion Criteria
1) Clinical indication for AVR for native valve predominant AR defined as:
a. Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade 3+ or 4+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory.
OR
b. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage* from AR with unanimous assessment from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR.
2) The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve.
3) Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion Criteria
1) Confirmed moderate (2+) or less AR severity by core laboratory evaluation.
2) Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions.
3) Subject is high-risk for SAVR as determined by the local heart team.
