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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

REVIVAL Trial 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

REVIVAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through trial completion, estimated to be 10 years

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

REVIVAL 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER

368 Previous Clinical Trials

300,950 Total Patients Enrolled

2 Trials studying Aortic Valve Disease

147 Patients Enrolled for Aortic Valve Disease

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

679,869 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prospective results is this medical trial striving to achieve?

"This clinical trial, projected to last for 10 years until completion, is primarily assessing the capacity of 6 patients per centre each year in order to evaluate its feasibility. Secondary objectives include measuring the rate of valve thrombosis (blood clots not caused by infection that impede or obstruct blood flow) through patient follow-up; recording any aortic valve re-interventions (surgical/percutaneous repairs and replacements); and monitoring stroke/systemic embolisms rates during this duration as well."

Answered by AI

Is the trial open to senior citizens over 65 years of age?

"This clinical trial seeks participants who have attained the age of majority and are less than 60 years old."

Answered by AI

Do my qualifications meet the criteria for this experiment?

"In order for potential participants to be accepted into the trial, they must possess aortic valve disease and fall within an 18-60 year old age bracket. This clinical study is recruiting 43 individuals in total."

Answered by AI

Are prospective participants currently able to join this research endeavor?

"According to the clinicaltrials.gov portal, this particular medical study is not actively enrolling patients at this time. It was first published on April 29th 2019 and last updated November 21st 2022; however, there are many other trials recruiting now with a total of 29 available research opportunities."

Answered by AI

Recent research and studies

BMJ OpenJournal

Ross for Valve Replacement in Adults (REVIVAL) Pilot Trial: Rationale and Design of a Randomised Controlled Trial

Whitlock, Richard, Emilie Belley-Cote, Filip Rega, Michael W.A. Chu, Graham R McClure, Hanna Hronyecz, Peter Verbrugghe, et al.. 2021. “Ross for Valve Replacement in Adults (REVIVAL) Pilot Trial: Rationale and Design of a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-046198.

clinicaltrials.govStudy

Ross for Valve Replacement in AduLts Trial

Richard Whitlock 2019. "Ross for Valve Replacement in AduLts Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03798782.