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Valve Replacement

Optimize PRO Study

N/A
Waitlist Available
Led By Steven Yakubov, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Aortic Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
AR
Canting (Evolut FX Addendum Only)
Depth of Implant (Evolut FX Only)
+2 more
Other study objectives
All-cause mortality or all-stroke
Hospital re-admission rates

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Primary CohortExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,367 Total Patients Enrolled
Steven Yakubov, MDPrincipal InvestigatorOhioHealth
Kendra Grubb, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
5 Total Patients Enrolled
Josep Rodés-Cabau, MDStudy ChairLaval University
6 Previous Clinical Trials
1,212 Total Patients Enrolled
Suneet Mittal, MDStudy ChairValley Health System
8 Previous Clinical Trials
3,199 Total Patients Enrolled
Tamim Nazif, MDStudy ChairColumbia - New York Presbyterian
1 Previous Clinical Trials
60 Total Patients Enrolled
Hemal Gada, MDStudy ChairUPMC Pinnacle
1 Previous Clinical Trials
532 Total Patients Enrolled
Douglas Fraser, MDStudy ChairManchester Royal Infirmary
~128 spots leftby Dec 2025
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