NCT03635424

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

Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Multi-center, prospective, single arm All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years

Conditions

• Bicuspid Aortic Valve

Interventions

Type	Name	Description
DEVICE	Medtronic TAVR Systems	Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-11-13
• Completion: 2030-12-01
• First posted: 2018-08-17
• Last updated: 2025-10-21
• Results posted: 2020-12-21

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study