CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 1,746 enrolled
Drug / intervention
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01586910
NCT01586910N/AActive

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Medtronic Cardiovascular·interventional·Posted Apr 27, 2012·Updated Jun 24, 2026

In Brief

A clinical study evaluating Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), and 1 other intervention for Severe Aortic Stenosis. Active but no longer recruiting, targeting 1,746 participants across 86 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Denmark, Germany, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

N/AActive
2012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2018
Study CompletionNov 1, 2026
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.2 years ago

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)device

Surgical Aortic Valve Replacement (SAVR)procedure

Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)device