NCT02701283

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,223 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Detailed description

Multi-center, international, prospective, randomized, interventional, pre-market. Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years. The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic Transcatheter Aortic Valve Replacement Systems	Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
DEVICE	Surgical Aortic Valve Replacement (SAVR)	Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-04-01
• Completion: 2029-06-01
• First posted: 2016-03-08
• Last updated: 2026-03-19
• Results posted: 2021-09-09

Locations

87 sites across 7 countries: United States, Australia, Canada, France, Japan, Netherlands, New Zealand

Regulatory

• FDA-regulated device study