Active, not recruitingNCT03635424

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Name: Yale New Haven Hospital
Address: New Haven, CT

Medtronic CardiovascularMultiple US sitesView on ClinicalTrials.gov

AI Description

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

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Who can join: adult, older adult
Participants: 150
Expected completion: 2030-12
Funded by: industry

Conditions studied

Bicuspid Aortic Valve

What is being tested

DEVICE: Medtronic TAVR Systems

What it measures

Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure., Device success rate, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days), 7 days
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure., Rate of of all-cause mortality or disabling stroke rate at 30 days, 30 days