Status:
COMPLETED
Ross for Valve Replacement in AduLts Trial
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve. The...
Detailed Description
Heart valves help control blood flow through the heart and, if diseased, may need to be replaced. After having a heart valve replaced, patients have a higher risk of death than people who have not had...
Eligibility Criteria
Inclusion
- Age 18-60 years
- Undergoing clinically indicated aortic valve replacement
- Provided written informed consent
Exclusion
- Previous valve replacement not in the aortic position
- Patients undergoing concomitant CABG or other valve procedure during aortic valve replacement
- Known connective tissue disease
- Severe (grade 3 or 4) right or left ventricular dysfunction
- Pulmonary valve dysfunction or anomaly not compatible with the Ross procedure (as determined by the consulting cardiac surgeon)
- Life expectancy less than 5 years (as determined by the consulting cardiac surgeon)
- Documented severe aortic insufficiency not solely due to leaflet issue
- Previous intervention on the pulmonary valve
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03798782
Start Date
April 29 2019
End Date
December 22 2023
Last Update
January 31 2024
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2