Mitral RegurgitationEVOLVE-MRNCT03705312
MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR
A study testing Transcatheter mitral valve repair and Guideline-directed medical therapy in people with Mitral Regurgitation and Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Heart Failure, Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
- What is being tested?
- Transcatheter mitral valve repair and Guideline-directed medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2019to Jan 2022
- 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
- Moderate functional mitral regurgitation (2+, 2-3+)
- Left ventricular ejection fraction >20%
- LVEDV 75-110 ml/m2
- Symptomatic heart failure (NYHA Class II-IV)
Who cannot join
- Left ventricular ejection fraction < 20%
- Severe functional mitral regurgitation
- Recent coronary artery bypass graft surgery (CABG)
- Untreated significant coronary artery disease
- Mitral valve area < 4.0cm2
- Severe pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Anita W Asgar, MD, 5143763330, anita.asgar@umontreal.ca
About this study
Official title: EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.
Read the detailed description
Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.
Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity.
EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.
- Conditions
- Mitral Regurgitation, Heart Failure, Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
- Being tested
- Transcatheter mitral valve repair, Guideline-directed medical therapy
- Keywords
- mitral regurgitation, transcatheter mitral valve repair
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter mitral valve repairDevice
Also called MitraClip
Transcatheter mitral valve repair performed using the MitraClip device
Guideline-directed medical therapyOther
Standard medical therapy for heart failure as recommended by HF guidelines
| Study group | Role | What they receive |
|---|---|---|
| Guideline-directed medical therapy | Placebo comparator | Standard guideline-directed medical treatment for heart failure Receives: Other: Guideline-directed medical therapy |
| Transcatheter Mitral valve repair | Experimental | MitraClip treatment Receives: Device: Transcatheter mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular diastolic remodelling
Change in indexed left ventricular diastolic volume (LVEDV)
Measured: 12 months
Functional capacity as measured by 6 minute walk test
Change in distance walked on six-minute walk test
Measured: 12 months
Secondary outcomes (3)
Mitral regurgitation Severity (RV)
Change in mitral regurgitant volume
Measured: 12 months
Mitral regurgitation Severity (EROA)
Change in effective regurgitant orifice area
Measured: 12 months
Quality of Life Measurement
Change in indices of quality of life as measured by Kansas City Cardiomyopathy Questionnaire. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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 posted15 Oct 2018
- Study start22 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Anita W Asgar, MD, Principal investigator, Montreal Heart InstituteAnique Ducharme, MD, Principal investigator, Montreal Heart InstituteJean L Rouleau, MD, Study chair, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705312
- Sponsor's protocol ID
- 2019-2458
- Acronym
- EVOLVE-MR
- Status last verified
- Oct 2018
- First submitted
- 4 Aug 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure
- ClinicalTrials.gov ID
- NCT03705312
- Acronym / sponsor ID
- EVOLVE-MR / 2019-2458
- Conditions
- Mitral Regurgitation, Heart Failure, Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
- Keywords
- mitral regurgitation, transcatheter mitral valve repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Oct 2018 (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 the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.
Detailed description
Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.
Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity.
EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
| Arm | Type | Receives |
|---|---|---|
| Guideline-directed medical therapy | Placebo comparator | Other: Guideline-directed medical therapyStandard guideline-directed medical treatment for heart failure |
| Transcatheter Mitral valve repair | Experimental | Device: Transcatheter mitral valve repairMitraClip treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate functional mitral regurgitation (2+, 2-3+)
- Left ventricular ejection fraction >20%
- LVEDV 75-110 ml/m2
- Symptomatic heart failure (NYHA Class II-IV)
Key exclusion criteria (6 listed)
- Left ventricular ejection fraction < 20%
- Severe functional mitral regurgitation
- Recent coronary artery bypass graft surgery (CABG)
- Untreated significant coronary artery disease
- Mitral valve area < 4.0cm2
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 |
|---|---|---|
| Transcatheter mitral valve repairAlso: MitraClipTranscatheter mitral valve repair performed using the MitraClip device | Device | Transcatheter Mitral valve repair |
| Guideline-directed medical therapyStandard medical therapy for heart failure as recommended by HF guidelines | Other | Guideline-directed medical therapy |
Primary outcome
Left ventricular diastolic remodelling
Time frame: 12 months
Change in indexed left ventricular diastolic volume (LVEDV)
Functional capacity as measured by 6 minute walk test
Time frame: 12 months
Change in distance walked on six-minute walk test
3 secondary outcomes
Mitral regurgitation Severity (RV)
Time frame: 12 months
Mitral regurgitation Severity (EROA)
Time frame: 12 months
Quality of Life Measurement
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Anita W Asgar, MD principal investigator
Montreal Heart Institute
Anique Ducharme, MD principal investigator
Montreal Heart Institute
Jean L Rouleau, MD study chair
Montreal Heart 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 Transcatheter mitral valve repair and Guideline-directed medical therapy in people with Mitral Regurgitation and Heart Failure, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita W Asgar, MD (5143763330 ext. 3800, anita.asgar@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular diastolic remodelling (time frame: 12 months). The study lists 2 primary outcomes in all. 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 14 Aug 2019.