Ross for Valve Replacement in AduLts Trial

NCT03798782 | Completed DMC

• 1 other identifier: REVIVAL-2018
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Cardiac surgery; Aortic valve replacement; Ross procedure

Outcome Measures

Primary Outcomes (4)

• 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)

  The primary outcome is the rate of survival free of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) over duration of follow-up. Assessment of this composite over time is particularly important, as the Ross procedure may show initial benefit secondary to thromboembolic and bleeding reduction, however should the technique show high late rates of reoperation as suggested in some observational literature, the effect magnitude may change significantly over time.

  Through trial completion, estimated to be 10 years

• Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial

  The outcome measures of the pilot trial, in order of importance, are: To evaluate the capacity to enroll a mean of 6 patients per centre per year.

  Through completion of the pilot trial, estimated to be 3 years

• The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial

  To determine the rate of compliance with randomization allocation.

  Through completion of the pilot trial, estimated to be 3 years

• Measure the proportions of type of conventional valve used in the pilot trial

  To validate the proportion of mechanical (at least 65%) versus biological (at most 35%) valves in the conventional arm.

  Through completion of the pilot trial, estimated to be 3 years

Secondary Outcomes (13)

• The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up

  Through trial completion, estimated to be 10 years

• The rate of stroke or systemic thromboembolism over the duration of patient follow-up

  Through trial completion, estimated to be 10 years

• The rate of valve thrombosis per VARC criteria over the duration of patient follow-up

  Through trial completion, estimated to be 10 years

• The rate of operated-on valve reintervention over the duration of patient follow-up

  Through trial completion, estimated to be 10 years

• Rate of mortality within 30 days post-operatively

  30 days

Other Outcomes (5)

• Rate of myocardial infarction

  30 days postoperatively

• Rate of acute renal failure by Acute Kidney Injury Network classification

  30 days postoperatively

• Rate of need for acute renal replacement therapy

  30 days postoperatively

Study Arms (2)

Ross procedure

EXPERIMENTAL

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.

Procedure: Ross procedure

Conventional aortic valve replacement

ACTIVE COMPARATOR

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.

Procedure: Conventional aortic valve replacement

Interventions

Ross procedure 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.

Ross procedure

Conventional aortic valve replacement 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.

Conventional aortic valve replacement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Undergoing clinically indicated aortic valve replacement
• Provided written informed consent

You may not qualify if:

• Previous valve replacement not in the aortic position
• Patients undergoing concomitant CABG or other valve procedure during aortic valve replacement
• Known connective tissue disease
• Severe (grade 3 or 4) right or left ventricular dysfunction
• Pulmonary valve dysfunction or anomaly not compatible with the Ross procedure (as determined by the consulting cardiac surgeon)
• Life expectancy less than 5 years (as determined by the consulting cardiac surgeon)
• Documented severe aortic insufficiency not solely due to leaflet issue
• Previous intervention on the pulmonary valve

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 34531204 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Richard Whitlock, MD, PhD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 10, 2019
• Study Start: April 29, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 22, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CA (1)