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Procedure

Aortic Valve Replacement vs Ross Procedure for Aortic Valve Stenosis (REVIVAL Trial)

N/A
Waitlist Available
Led By Richard Whitlock, MD, PhD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through trial completion, estimated to be 10 years
Awards & highlights

Summary

This trial compares the Ross Procedure (RP) with Biologic or Mechanical Aortic Valve Replacement (AVR) in young adults. The RP uses the patient's own valve in the pulmonary position, which is less stressed than the aortic valve.

Eligible Conditions
  • Aortic Valve Disease
  • Aortic Valve Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through trial completion, estimated to be 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through trial completion, estimated to be 10 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
Full trial - The rate of survival free of a composite of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention)
Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial
Measure the proportions of type of conventional valve used in the pilot trial
+1 more
Secondary outcome measures
Mean aortic valve gradient
Mean pulmonic valve gradient
Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up
+10 more
Other outcome measures
Rate of acute renal failure by Acute Kidney Injury Network classification
Rate of deep mediastinal wound infection
Rate of myocardial infarction
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ross procedureExperimental Treatment1 Intervention
The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root.
Group II: Conventional aortic valve replacementActive Control1 Intervention
The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ross procedure
2019
N/A
~50

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER
369 Previous Clinical Trials
300,438 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
147 Patients Enrolled for Aortic Valve Disease
Population Health Research InstituteLead Sponsor
157 Previous Clinical Trials
686,604 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
147 Patients Enrolled for Aortic Valve Disease
Richard Whitlock, MD, PhDPrincipal InvestigatorPopulation Health Research Institute
2 Previous Clinical Trials
1,170 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
62 Patients Enrolled for Aortic Valve Disease
~7 spots leftby Sep 2025
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