Clinical trial NCT03798782: Ross for Valve Replacement in AduLts Trial
Official title: Ross for Valve Replacement in AduLts Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Cardiac surgery
Aortic valve replacement
Ross procedure
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2019-01-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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.

The investigators will perform a 3-year feasibility study in seven sites, in Canada and abroad, to test the study design and ability to do a larger, conclusive study comparing the impact of the Ross procedure to standard valve replacement on survival without valve-related life-threatening complications. Patients will be randomized, like flipping a coin, to receive the Ross or standard valve surgery. The goals are 1) to evaluate if the investigators can recruit 6 patients per site per year, 2) to test if the assigned procedure is performed in over 90% of study patients, and 3) to see how many mechanical vs. tissue valves are used in the standard valve group. Patients eligible but not enrolled in the trial will be asked if the investigators can collect some data on how they do after their surgery. If the investigators show the study is feasible, they will proceed to the full study and will include the feasibility patients in the full study.

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: Full trial primary outcome - 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: Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial
timeFrame: Through completion of the pilot trial, estimated to be 3 years
measure: The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial
timeFrame: Through completion of the pilot trial, estimated to be 3 years
measure: Measure the proportions of type of conventional valve used in the pilot trial
timeFrame: Through completion of the pilot trial, estimated to be 3 years
Secondary outcomes:
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: Annually 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:
citation: Whitlock R, Belley-Cote E, Rega F, Chu MWA, McClure GR, Hronyecz H, Verbrugghe P, Devereaux PJ, Bangdiwala S, Eikelboom J, Brady K, Sharifulin R, Bogachev-Prokophiev A, Stoica S. Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial. BMJ Open. 2021 Sep 16;11(9):e046198. doi: 10.1136/bmjopen-2020-046198.