NCT01586910

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,746 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
PROCEDURE	Surgical Aortic Valve Replacement (SAVR)
DEVICE	Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Timeline

• Start date: 2012-04-01
• Primary completion: 2018-07-01
• Completion: 2026-11-01
• First posted: 2012-04-27
• Last updated: 2025-10-28
• Results posted: 2019-09-17

Locations

86 sites across 9 countries: United States, Canada, Denmark, Germany, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study