Clinical trial NCT03894787: Ross for Valve Replacement in Adults - Registry
Official title: Ross for Valve Replacement in AduLts (REVIVAL) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Ross procedure
Conventional aortic valve replacement
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2019-03-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet eligibility criteria of the REVIVAL trial, but are not included in the trial due to patient or clinician factors, will be asked to participate in the REVIVAL registry.

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.

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

Primary outcomes:
measure: Evaluation of systematic differences between registry and trial patients
timeFrame: Through REVIVAL Trial completion, estimated to be 10 years
Secondary outcomes:
measure: Evaluate the number of patients meeting eligibility criteria for the REVIVAL trial per month who are not enrolled into the trial.
timeFrame: Through completion of the pilot trial, estimated to be 3 years
measure: Evaluate the proportion of Ross procedures compared to conventional aortic valve replacement.
timeFrame: Through completion of the pilot trial, estimated to be 3 years
measure: 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)
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of stroke or systemic thromboembolism over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of valve thrombosis per VARC criteria over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of operated-on valve reintervention over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: Rate of mortality within 30 days post-operatively.
timeFrame: 30 days
measure: Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of operated-valve endocarditis over the duration of patient follow-up
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of aortic valve re-intervention over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: The rate of pulmonary valve re-intervention over the duration of patient follow-up.
timeFrame: Through trial completion, estimated to be 10 years
measure: Mean aortic valve gradient.
timeFrame: Through trial completion, estimated to be 10 years
measure: Mean pulmonic valve gradient
timeFrame: Through trial completion, estimated to be 10 years
measure: Severity of aortic valve regurgitation.
timeFrame: Through trial completion, estimated to be 10 years
measure: Severity of pulmonic valve regurgitation
timeFrame: Through trial completion, estimated to be 10 years
Other outcomes:
measure: Rate of myocardial infarction
timeFrame: 30 days postoperatively
measure: Rate of acute renal failure by Acute Kidney Injury Network classification
timeFrame: 30 days postoperatively
measure: Rate of need for acute renal replacement therapy
timeFrame: 30 days postoperatively
measure: Rate of surgical re-exploration of the mediastinum for bleeding
timeFrame: 30 days postoperatively
measure: Rate of deep mediastinal wound infection
timeFrame: 30 days postoperatively
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Richard Whitlock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: