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).

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

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)

Sponsors & Collaborators

• Medtronic Cardiovascular

  lead INDUSTRY

Principal Investigators

• Stephan Windecker, MD, PhD · Bern University Hospital

• Rüdiger Lange, MD, PhD · Deutsches Herzzentrum München

• Thomas Walther, MD, PhD · Kerckhoff Klinik

• Michael J. Reardon, MD · The Methodist Hospital Research Institute

• David H. Adams, MD · Icahn School of Medicine at Mount Sinai

• Nicolas M. Van Mieghem, MD · Erasmus Medical Center

• Patrick W. Serruys, MD, PhD · National Heart & Lung Institute of Imperial College in London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2018-07-31

Completion

2026-11-30

FDA Device

Yes

Countries

• United States
• Canada
• Denmark
• Germany
• Netherlands
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations