Optimize PRO Study

Recruiting in Palo Alto (17 mi)

+60 other locations

Overseen byKendra Grubb, MD

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 this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.

Research Team

Tamim Nazif, MD

Principal Investigator

Columbia - New York Presbyterian

Douglas Fraser, MD

Principal Investigator

Manchester Royal Infirmary

Steven Yakubov, MD

Principal Investigator

OhioHealth

Kendra Grubb, MD

Principal Investigator

Emory University

Josep Rodés-Cabau, MD

Principal Investigator

Laval University

Suneet Mittal, MD

Principal Investigator

Valley Health System

Hemal Gada, MD

Principal Investigator

UPMC Pinnacle

Eligibility Criteria

Inclusion Criteria

Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations;

Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;

Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits;

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