Aortic Valve DiseaseREVIVALNCT03798782
Ross for Valve Replacement in AduLts Trial
A study testing Ross procedure and Conventional aortic valve replacement in people with Aortic Valve Disease, run by Population Health Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Ross procedure and Conventional aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2019to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Undergoing clinically indicated aortic valve replacement
- Provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Ross procedure, Conventional aortic valve replacement
- Keywords
- Cardiac surgery, Aortic valve replacement, Ross procedure
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ross procedureProcedure or surgery
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 replacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Perioperative (index surgery only) Intraoperative: After administration of protamine, delay of chest closure for bleeding > 500 mL/hr requiring packing and transfusion of more than 3 units red blood cells /whole blood.
Upon leaving OR to 48hrs postop (modified BARC type 4)
- Intracranial bleeding within 48hrs
- Reoperation after sternum closure for purpose of controlling bleeding or relief of tamponade
- Transfusion of ≥ 5 units packed red blood cells /whole blood in the 48hr period
- Chest tube output ≥ 2L in the first 24hr
Non-perioperative Per the International Society of Thrombosis and Hemostasis (ISTH) major bleeding definition.
Measured: Through trial completion, estimated to be 10 years
The rate of stroke or systemic thromboembolism over the duration of patient follow-up
Stroke is acute focal brain dysfunction due to a vascular cause lasting ≥ 24 hrs in the absence of brain imaging or requires evidence of acute stroke on brain imaging (if there is a stroke documented by CT or MRI or at autopsy, the duration of symptoms/signs may be < 24 hours). Stroke is divided into 3 types: ischemic stroke, hemorrhagic stroke, and undetermined stroke. If death occurs within 24 hours, the neurological deficit must persist up to the time of death.
Systemic arterial embolism is an abrupt vascular insufficiency associated with evidence of arterial occlusion in the absence of other likely mechanisms. Clinical signs/symptoms must be consistent with embolic arterial occlusion, there must be clear evidence of abrupt occlusion of a systemic artery, with at least one type of supporting evidence (surgical report indicating evidence of arterial embolism, pathological specimens related to embolism removal, imaging evidence consistent with arterial embolism, or autopsy report).
Measured: Through trial completion, estimated to be 10 years
The rate of valve thrombosis per VARC criteria over the duration of patient follow-up
Valve thrombosis is defined as any thrombus not caused by infection attached to or near an operated valve that occludes part of the blood flow path, interferes with valve function, or is large enough to warrant treatment. Valve thrombus found at autopsy in a patient whose cause of death was not valve related or found at operation for and unrelated indication is to be counted as valve thrombosis.
Measured: Through trial completion, estimated to be 10 years
The rate of operated-on valve reintervention over the duration of patient follow-up
Rate of valve reintervention Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve.
Measured: Through trial completion, estimated to be 10 years
Rate of mortality within 30 days post-operatively
Rate of mortality within 30 days post-operatively
Measured: 30 days
Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up
The SF-36 is a health related quality of life questionnaire that measure eight health domains and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The questionnaire is calibrated such that scored values of 50 represent the norm and higher scored values according to the scoring key represent a more favourable health state. A baseline score will be obtained prior to the patient's surgery and the SF-36 will be administered annually thereafter over the duration of patient follow-up.
Measured: Annually through trial completion, estimated to be 10 years
The rate of operated-valve endocarditis over the duration of patient follow-up
Defined as any infection involving a valve on which an operation has been performed. The diagnosis is based on one or more of the following: 1) reoperation with evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histologic or bacteriologic studies; 2) autopsy findings of abscess, pus, or vegetation involving an operated-on valve; or 3) the meeting of Duke criteria for endocarditis.
Measured: Through trial completion, estimated to be 10 years
The rate of aortic valve re-intervention over the duration of patient follow-up
Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the aortic position.
Measured: Through trial completion, estimated to be 10 years
The rate of pulmonary valve re-intervention over the duration of patient follow-up
Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the pulmonary position.
Measured: Through trial completion, estimated to be 10 years
Mean aortic valve gradient
Measured through echocardiography
Measured: Through trial completion, estimated to be 10 years
Mean pulmonic valve gradient
Measured through echocardiography
Measured: Through trial completion, estimated to be 10 years
Severity of aortic valve regurgitation
Measured through echocardiography, categorized as mild, moderate, or severe
Measured: Through trial completion, estimated to be 10 years
Severity of pulmonic valve regurgitation
Measured through echocardiography, categorized as mild, moderate, or severe
Measured: Through trial completion, estimated to be 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start29 Apr 2019
- Primary completion1 Oct 2022
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Richard Whitlock, McMaster University
- Investigators
- Richard Whitlock, MD, PhD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798782
- Sponsor's protocol ID
- REVIVAL-2018
- Acronym
- REVIVAL
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34531204
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ross for Valve Replacement in AduLts Trial
- ClinicalTrials.gov ID
- NCT03798782
- Acronym / sponsor ID
- REVIVAL / REVIVAL-2018
- Conditions
- Aortic Valve Disease
- Keywords
- Cardiac surgery, Aortic valve replacement, Ross procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ross procedure | Experimental | Procedure: Ross procedureThe 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. |
| Conventional aortic valve replacement | Active comparator | Procedure: Conventional aortic valve replacementThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Undergoing clinically indicated aortic valve replacement
- Provided written informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ross procedureThe 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. | Procedure or surgery | Ross procedure |
| Conventional aortic valve replacementThe 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 or surgery | Conventional aortic valve replacement |
Primary outcome
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)
Time frame: Through trial completion, estimated to be 10 years
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.
Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial
Time frame: Through completion of the pilot trial, estimated to be 3 years
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.
The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial
Time frame: Through completion of the pilot trial, estimated to be 3 years
To determine the rate of compliance with randomization allocation.
Measure the proportions of type of conventional valve used in the pilot trial
Time frame: Through completion of the pilot trial, estimated to be 3 years
To validate the proportion of mechanical (at least 65%) versus biological (at most 35%) valves in the conventional arm.
13 secondary outcomes
The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
The rate of stroke or systemic thromboembolism over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
The rate of valve thrombosis per VARC criteria over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
The rate of operated-on valve reintervention over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
Rate of mortality within 30 days post-operatively
Time frame: 30 days
Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up
Time frame: Annually through trial completion, estimated to be 10 years
The rate of operated-valve endocarditis over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
The rate of aortic valve re-intervention over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
The rate of pulmonary valve re-intervention over the duration of patient follow-up
Time frame: Through trial completion, estimated to be 10 years
Mean aortic valve gradient
Time frame: Through trial completion, estimated to be 10 years
Mean pulmonic valve gradient
Time frame: Through trial completion, estimated to be 10 years
Severity of aortic valve regurgitation
Time frame: Through trial completion, estimated to be 10 years
Severity of pulmonic valve regurgitation
Time frame: Through trial completion, estimated to be 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 34531204Whitlock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Whitlock, MD, PhD principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ross procedure and Conventional aortic valve replacement in people with Aortic Valve Disease, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Through trial completion, estimated to be 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.