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Valve Replacement
Primary Cohort for Aortic Stenosis
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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
AR
Canting (Evolut FX Addendum Only)
Depth of Implant (Evolut FX Only)
+2 moreOther outcome measures
All-cause mortality or all-stroke
Hospital re-admission rates
Trial Design
1Treatment groups
Experimental Treatment
Group I: Primary CohortExperimental Treatment1 Intervention
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Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,373 Total Patients Enrolled
Steven Yakubov, MDPrincipal InvestigatorOhioHealth
Kendra Grubb, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
5 Total Patients Enrolled
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