TAVI vs SAVR for Aortic Stenosis

(SURTAVI Trial)

Recruiting at 86 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiovascular

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael J. Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

David H. Adams, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Patrick W. Serruys, MD, PhD

Principal Investigator

National Heart & Lung Institute of Imperial College in London

Nicolas M. Van Mieghem, MD

Principal Investigator

Erasmus Medical Center

Rüdiger Lange, MD, PhD

Principal Investigator

Deutsches Herzzentrum München

Thomas Walther, MD, PhD

Principal Investigator

Kerckhoff Klinik

Stephan Windecker, MD, PhD

Principal Investigator

Bern University Hospital

Eligibility Criteria

This trial is for people with severe, symptomatic Aortic Stenosis who are at intermediate risk for surgery. They must be of legal age to consent and have a predicted surgical mortality risk between ≥3% and <15%. Participants should commit to follow-up visits, not have had recent strokes or heart attacks, no severe lung disease (COPD), uncontrolled atrial fibrillation, or conditions that prevent anticoagulation.

Inclusion Criteria

I have severe narrowing of my heart's aortic valve with specific measurements.

You have other health problems that make the surgery risk between 3% and 15% at 30 days according to the Heart Team.

I am old enough to make my own medical decisions according to local laws.

Exclusion Criteria

I have severe liver failure.

My lung blood pressure is high.

I am considered frail based on my age, mobility, living situation, weight, grip strength, daily activity ability, and protein levels.

Treatment Details

Interventions

• Medtronic CoreValve® Evolut R System (Transcatheter Aortic Valve Implantation)
• Medtronic CoreValve® System (Transcatheter Aortic Valve Implantation)
• Surgical Aortic Valve Replacement (SAVR) (Surgical Aortic Valve Replacement)

Trial Overview The study compares the safety and effectiveness of two treatments: TAVI using Medtronic CoreValve® Systems versus traditional Surgical Aortic Valve Replacement (SAVR). Patients will either be randomly assigned to one of these treatments or receive TAVI in a non-randomized phase.

Participant Groups

Group I: Medtronic CoreValve® System TAVI Experimental Treatment 2 Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Group II: SAVR Active Control 1 Intervention

Surgical Aortic Valve Replacement (SAVR)

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University