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Transcatheter Aortic Valve Replacement (TAVR)

Medtronic Evolut™ PRO+ System for Aortic Valve Stenosis

N/A
Waitlist Available
Led By Paul Sorajja, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually through 5 years
Awards & highlights

Study Summary

This study is evaluating whether a new heart valve may help individuals with aortic stenosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually through 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and annually through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Kidney Injury
Change From Baseline in Global Longitudinal Strain (GLS)
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
+12 more
Other outcome measures
All Stroke (Disabling and Non-disabling)
All-cause and Cardiovascular Mortality
Bioprosthetic Valve Dysfunction (BVD)
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Medtronic Evolut™ PRO+ SystemExperimental Treatment1 Intervention
All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,321 Total Patients Enrolled
22 Trials studying Aortic Valve Stenosis
15,619 Patients Enrolled for Aortic Valve Stenosis
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
1,233 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
650 Patients Enrolled for Aortic Valve Stenosis
Josep Rodes-Cabau, MDPrincipal InvestigatorFondation IUCPQ
6 Previous Clinical Trials
1,330 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
650 Patients Enrolled for Aortic Valve Stenosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
2021. "Medtronic Evolut™ EXPAND TAVR I Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639258.
~3 spots leftby Apr 2025
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