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Optimize PRO Study

NCT04091048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1127

Last updated 2026-01-13

Study results available
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Summary

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.

Conditions

  • Symptomatic Aortic Stenosis

Interventions

DEVICE

Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

Aortic valve replacement

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Steven Yakubov, MD · OhioHealth

  • Kendra Grubb, MD · Emory University

  • Josep Rodés-Cabau, MD · Laval University

  • Suneet Mittal, MD · Valley Health System

  • Tamim Nazif, MD · Columbia - New York Presbyterian

  • Hemal Gada, MD · UPMC Pinnacle

  • Douglas Fraser, MD · Manchester Royal Infirmary

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2023-12-15
Completion
2024-11-13
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04091048 on ClinicalTrials.gov