Ross for Valve Replacement in Adults - Registry (REVIVAL-Reg)

Population Health Research Institute (PHRI)

Status: Completed

Conditions: Aortic Valve Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03894787

REVIVAL Reg - 2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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