Ross for Valve Replacement in AduLts Trial

NCT ID: NCT03798782

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2023-12-22

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.

Conditions

Aortic Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ross procedure

The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root.

Group Type: EXPERIMENTAL

Ross procedure

Intervention Type: PROCEDURE

The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures.

Conventional aortic valve replacement

The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.

Group Type: ACTIVE_COMPARATOR

Conventional aortic valve replacement

Intervention Type: PROCEDURE

The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.

Interventions

Ross procedure

The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures.

Intervention Type: PROCEDURE

Conventional aortic valve replacement

The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.

Intervention Type: PROCEDURE

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

Richard Whitlock

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Whitlock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34531204 (View on PubMed)

Other Identifiers

REVIVAL-2018

Identifier Type: -

Identifier Source: org_study_id