Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT) for Constriction, Pathologic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Constriction, Pathologic+3 More
Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT) - Device
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the Medtronic TAVR System is safe and effective for patients with moderate, symptomatic aortic stenosis.

Eligible Conditions
  • Constriction, Pathologic
  • Aortic Valve Stenosis

Treatment Effectiveness

Study Objectives

4 Primary · 11 Secondary · Reporting Duration: 2 years

1 year
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
2 years
All-cause mortality
Composite of all-cause mortality and heart failure events (inclusive of heart failure hospitalizations)
Composite of all-cause mortality and heart failure events (inclusive of hospitalizations)
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations (inclusive of all aortic valve replacement (AVR))
Composite of all-cause mortality, heart failure event, or aortic valve replacement or reintervention
Composite rate of all-cause mortality or unplanned procedure-related or aortic valve related hospitalization.
Days alive and free of unplanned cardiovascular hospitalizations
Days alive and free of unplanned cardiovascular hospitalizations (inclusive of all AVR)
Heart failure events (inclusive of hospitalizations)
Unplanned cardiovascular hospitalizations
Unplanned cardiovascular hospitalizations (exclusive of AVR)
30 days
Composite of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.

Trial Safety

Trial Design

2 Treatment Groups

Clinical site determined guideline-directed management and therapy (GDMT) alone
1 of 2
Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy ...
1 of 2
Active Control
Experimental Treatment

650 Total Participants · 2 Treatment Groups

Primary Treatment: Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT) · No Placebo Group · N/A

Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT)
Device
Experimental Group · 1 Intervention: Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT) · Intervention Types: Device
Clinical site determined guideline-directed management and therapy (GDMT) aloneNoIntervention Group · 1 Intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
74 Previous Clinical Trials
35,622 Total Patients Enrolled
7 Trials studying Constriction, Pathologic
7,549 Patients Enrolled for Constriction, Pathologic
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
722 Total Patients Enrolled
Stephan Windecker, Prof.Principal InvestigatorInselspital, Universitätsspital Bern
1 Previous Clinical Trials
1,707 Total Patients Enrolled
Josep Rodes-Cabau, MDPrincipal InvestigatorFondation IUCPQ
6 Previous Clinical Trials
691 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a max aortic velocity of 3.
You have a mean aortic gradient of at least 20.0 mmHg and less than 40.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.