Ventricular Remodeling, LeftEVOLVE-MRNCT03891823
Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)
A study testing MitraClip and Medical Therapy in people with Ventricular Remodeling, Left, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Remodeling, Left
- What is being tested?
- MitraClip and Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 8 Mar 2019to 15 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants must meet ALL of the following inclusion criteria in order to be eligible for this study:
- Male or female ≥18 years of age;
- Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
- Left ventricular ejection fraction (LVEF) >20%, as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
- Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-proBNP as follows:
- NT-proBNP > 300 pg/mL in patients with sinus rhythm
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- NT-proBNP > 600 pg/mL in patients with atrial fibrillation
- Treatment and compliance with medical therapy for heart failure for at least 30 days;
- Optimal medical therapy is defined by:
- Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), Entresto (valsartan/sacubitril), Ivabradine and aldosterone antagonist (as per the ACC/AHA Guidelines and Canadian Cardiovascular Society Heart Failure Guidelines or other therapies (including SGLT2 inhibitors) as judged by the HF specialist investigator on site and confirmed by the Clinical Eligibility Committee.
- Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
- The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip;
- Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m;
- Ability and willingness to give written informed consent and to comply with the requirements of the study.
Who cannot join
- Study participants meeting any of the following exclusion criteria by the day of randomization (visit 1) are NOT eligible for this study:
- Life expectancy less than 12 months due to non-cardiac conditions;
- ACC/AHA Stage D Heart Failure;
- Left ventricular ejection fraction ≤ 25%; indexed left ventricular end-diastolic volume ≥100 ml/m2;
- Severe (3-4+, 4+) secondary mitral regurgitation with an indication for intervention;
- Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
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- United Network for Organ Sharing (UNOS) status 1 heart transplantation (Canadian Cardiac Transplantation Network, CCTN, status 4) or prior orthotopic heart transplantation;
- Untreated clinically significant coronary artery disease requiring revascularization;
- CABG within prior 30 days;
- Percutaneous coronary intervention within prior 30 days;
- Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
- Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
- Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception;
- Women are considered not of childbearing potential if they:
- Have had a hysterectomy, a bilateral oophorectomy or tubal ligation prior to Baseline Visit.
- Are postmenopausal defined as no menses for at least 1 year and have a serum FSH level of 40 IU/L.
- Women of childbearing potential must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner.
- Mitral valve area <4.0 cm2 as assessed by planimetry of the mitral valve;
- Subjects in whom trans-esophageal echocardiography is contraindicated or is at high risk;
- Mitral leaflet anatomy which may preclude MitraClip implantation:
- Perforated mitral leaflets or clefts, lack of primary or secondary chordal support;
- Severe calcification in the grasping area;
- Rheumatic valve disease.
- Stroke or transient ischemic event within 30 days before randomization;
- Modified Rankin Scale >4 disability;
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months;
- Severe renal impairment defined as an Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula;
- Severe anemia requiring transfusional support or therapy with erythropoietin;
- Physical evidence of uncontrolled right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction;
- Aortic valve disease requiring surgery or transcatheter intervention;
- Significant tricuspid valve disease requiring surgical intervention or very severe tricuspid regurgitation with evidence of right ventricular dysfunction;
- Active infection requiring antibiotic therapy;
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease;
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy) and follow-up visits;
- Presence of any of the following:
- Pulmonary artery systolic pressure (PASP) > 70 mm Hg confirmed by right heart catheterization;
- Infiltrative cardiomyopathies.
- Any other condition(s) that would compromise the safety of the patient as judged by the site principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EValuation of Outcomes of MitraCLip for the Treatment of Moderate Functional Mitral ValvE Regurgitation In Heart Failure
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.
Read the detailed description
Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation.
Secondary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.
- To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.
Tertiary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months.
- To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months.
Exploratory Objectives
- To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, other echocardiographic parameters and health economic assessments.
- To evaluate the effects of MitraClip and medical therapy on all hospitalizations for decompensated heart failure, including episodes of outpatient treatment intensification in a HF clinic or emergency department visits, at 24 months.
- Conditions
- Ventricular Remodeling, Left
- Being tested
- MitraClip, Medical Therapy
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClipDevice
Study participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity.
Medical TherapyDrug
Study participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip | Experimental | Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up. Receives: Device: MitraClip; Drug: Medical Therapy |
| Medical Therapy | Active comparator | Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up. Receives: Device: MitraClip; Drug: Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Mitral Regurgitation
To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation
Measured: 24 months
Secondary outcomes (3)
Change in Mitral Regurgitation Severity at 24 Months
To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.
Measured: 24 months
Change in Mitral Regurgitation Severity at 12 Months
To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.
Measured: 12 months
Change in Quality of Life Assessment
To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start8 Mar 2019
- Primary completion28 Mar 2024
- Study completion15 May 2024
Why it stopped: Lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Remodeling, LeftStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study of MitraClip vs. medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Jean Rouleau, MD, Principal investigator, Montreal Heart InstituteAnique Ducharme, MD, Principal investigator, Montreal Heart InstituteSophie Tanguay, MSc, Study director, Montreal Health Innovations Coordinating Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891823
- Sponsor's protocol ID
- MHICC-2018-002
- Acronym
- EVOLVE-MR
- Status last verified
- May 2024
- First submitted
- 25 Mar 2019
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuation of Outcomes of MitraCLip for the Treatment of Moderate Functional Mitral ValvE Regurgitation In Heart Failure
- ClinicalTrials.gov ID
- NCT03891823
- Acronym / sponsor ID
- EVOLVE-MR / MHICC-2018-002
- Conditions
- Ventricular Remodeling, Left
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Mar 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.
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.
Detailed description
Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation.
Secondary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.
- To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.
Tertiary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months.
- To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months.
Exploratory Objectives
- To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, other echocardiographic parameters and health economic assessments.
- To evaluate the effects of MitraClip and medical therapy on all hospitalizations for decompensated heart failure, including episodes of outpatient treatment intensification in a HF clinic or emergency department visits, at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study of MitraClip vs. medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| MitraClip | Experimental | Device: MitraClip, Drug: Medical TherapyStudy of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up. |
| Medical Therapy | Active comparator | Device: MitraClip, Drug: Medical TherapyStudy of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Study participants must meet ALL of the following inclusion criteria in order to be eligible for this study:
- Male or female ≥18 years of age;
- Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
- Left ventricular ejection fraction (LVEF) >20%, as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
- Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-proBNP as follows:
Key exclusion criteria (39 listed)
- Study participants meeting any of the following exclusion criteria by the day of randomization (visit 1) are NOT eligible for this study:
- Life expectancy less than 12 months due to non-cardiac conditions;
- ACC/AHA Stage D Heart Failure;
- Left ventricular ejection fraction ≤ 25%; indexed left ventricular end-diastolic volume ≥100 ml/m2;
- Severe (3-4+, 4+) secondary mitral regurgitation with an indication for intervention;
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 |
|---|---|---|
| MitraClipStudy participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity. | Device | Medical Therapy, MitraClip |
| Medical TherapyStudy participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity. | Drug | Medical Therapy, MitraClip |
Primary outcome
Change In Mitral Regurgitation
Time frame: 24 months
To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation
3 secondary outcomes
Change in Mitral Regurgitation Severity at 24 Months
Time frame: 24 months
Change in Mitral Regurgitation Severity at 12 Months
Time frame: 12 months
Change in Quality of Life Assessment
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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.
Jean Rouleau, MD principal investigator
Montreal Heart Institute
Anique Ducharme, MD principal investigator
Montreal Heart Institute
Sophie Tanguay, MSc study director
Montreal Health Innovations Coordinating Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraClip and Medical Therapy in people with Ventricular Remodeling, Left, run by Montreal Heart 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 14 inclusion and 39 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: stopped early, as of the sponsor's last update on 30 May 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 was stopped early (reason given: Lack of recruitment.). Results are not available in the source record.
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?
Change In Mitral Regurgitation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2024.