Ross for Valve Replacement in Adults - Registry

NCT ID: NCT03894787

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2023-12-22

Brief Summary

This registry follows patients undergoing two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure or conventional aortic valve replacement using a biologic or mechanical heart valve. The Ross procedure replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. The REVIVAL Registry will run in parallel with the REVIVAL randomized trial.

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 a valve replaced. In young adult patients, replacing the aortic heart valve with a mechanical valve halves their life-span compared to other people their age. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. An operation, called the Ross procedure, replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. The Ross procedure aims to improve valve durability with less clotting, avoiding use of blood thinners. Patients and physicians need a large, high-quality study comparing the Ross procedure and standard valve replacement to know if either approach is better. In parallel to the REVIVAL Registry, a REVIVAL Randomized Trial will also take place.

Patients included in randomized trials often systematically differ from those who are not. By creating a registry of patients who are eligible for but not recruited into the REVIVAL trial, the investigators will better understand: 1) the reasons for not including these patients; 2) how those patients differ in terms of baseline characteristics from the trial cohort; 3) whether the outcomes of registry participants differ from those in the trial, assessed by treatment group. The registry will aid in understanding the generalizability of the results that the trial produces.

Conditions

Aortic Valve Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age 18-60 years

2. Undergoing clinically indicated aortic valve replacement

3. Provided written informed consent

Exclusion Criteria

1. Previous valve replacement not in the aortic position

2. Patients undergoing concomitant CABG or other valve procedure during aortic valve replacement

3. Known connective tissue disease

4. Severe (grade 3 or 4) right or left ventricular dysfunction

5. Pulmonary valve dysfunction or anomaly not compatible with the Ross procedure (as determined by the consulting cardiac surgeon)

6. Life expectancy less than 5 years (as determined by the consulting cardiac surgeon)

7. Documented severe aortic insufficiency not solely due to leaflet issue

8. Previous intervention on the pulmonary valve

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Whitlock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

REVIVAL Reg - 2018

Identifier Type: -

Identifier Source: org_study_id