Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Recruiting at7 trial locations

Overseen by Josep Rodes-Cabau, MD

Age: 65+

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 obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

Research Team

Paul Sorajja, MD

Principal Investigator

Allina Health System

Josep Rodes-Cabau, MD

Principal Investigator

Fondation IUCPQ

Eligibility Criteria

Inclusion Criteria

Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec

Dyspnea on rest or exertion

Angina

Treatment Details

Interventions

• Medtronic Evolut™ PRO+ System (Transcatheter Aortic Valve Replacement (TAVR))

Participant Groups

Group I: Medtronic Evolut™ PRO+ System Experimental Treatment 1 Intervention

All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.

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