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A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation

Status: Recruiting

The purpose of this research is the learn if an investigational device, the JenaValve Trilogy Heart Valve System, works just as well as a surgical valve aortic replacement (SAVR) for aortic regurgitation (AR). If you choose to participate in this study, you will be ?randomized? (i.e., randomly selected) into one of two groups: transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:
Must be a candidate for both the TAVR using the JenaValve Trilogy Heart Valve System and SAVR using a commercially approved bioprosthetic valve. Moderate to severe aortic valve leak. Agree to return for all required post-procedure follow-up visits.
Exclusion Criteria:
Aortic valve regurgitation not severe enough Too high risk for open heart surgery Refusal of surgical aortic valve replacement (SAVR) as a treatment option. Refusal of blood products Unable to undergo CT scan Active liver disease Chronic kidney disease stage 4 or 5 or dialysis
Interventions:

Drug/Device: JenaValve Trilogy Heart Valve System

Conditions:

Aortic regurgitation

Keywords:

Aortic regurgitation, JenaValve, SAVR, TAVR

Contact(s): Danielle Holmes - dholmes7@hfhs.org
Principal Investigator: Tiberio Frisoli
Principal Investigator ID: tfrisol1@hfhs.org
Phase: II
See this study on ClinicalTrials.gov

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