Ross for Valve Replacement in Adults - Registry

NCT03894787 | Completed DMC

• 1 other identifier: REVIVAL Reg - 2018
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Ross procedure; Conventional aortic valve replacement

Outcome Measures

Primary Outcomes (1)

• Evaluation of systematic differences between registry and trial patients

  The primary outcome of the REVIVAL registry is to examine for systematic differences between the demographics and outcomes of patients enrolled in the REVIVAL trial and patients not enrolled in the trial. We will use descriptive statistics including mean (standard deviation), median (interquartile range), and count (proportion) to describe the REVIVAL registry cohort.

  Through REVIVAL Trial completion, estimated to be 10 years

Secondary Outcomes (16)

• Evaluate the number of patients meeting eligibility criteria for the REVIVAL trial per month who are not enrolled into the trial.

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

• Evaluate the proportion of Ross procedures compared to conventional aortic valve replacement.

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

• 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)

  Through trial completion, estimated to be 10 years

• 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

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

Eligibility Criteria

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

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

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 29, 2019
• Study Start: June 3, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 22, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CA (1)