MITRAL REGURGITATIONPhase 4MITRA-CRTNCT02592889
(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)
A Phase 4 study testing MITRACLIP in people with MITRAL REGURGITATION, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- MITRAL REGURGITATION
- What is being tested?
- MITRACLIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Oct 2018
- Phase
- Phase 4
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CRT implanted between 6 months and 5 years before inclusion.
- Absence of clinical response to CRT defined by baseline NYHA 3 or NYHA 2 with a hospital admission for HF within the last 12 months.
- Adequate CRT therapy (correct stimulation in >98% heart beats).
- Correct position of the cardiac leads.
- Patients with atrial fibrillation will be included but balanced in both groups (the presence of AF is and independent factor of clinical response).
- Wide QRS (>0.12) and LBBB pre-CRT.
- LVEF 15-40% (as a surgical risk criteria).
- Left ventricle end-diastolic diameters <75 mm (as anatomical criteria for MitraClip feasibility).
Who cannot join
- Severe Renal Insufficiency (DFGe <30).
- Life expectancy < 1 year.
- Anatomical contraindication for MitraClip (in order to avoid selection biases, all patients must be Mitraclip candidates).
- Hemodynamic instability before inclusion defined by SBP <70 mmHg or the need of inotropic treatment within the previous 3 months.
- Inadequate treatment compliance or difficult follow-up.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic Barcelona
Barcelona, Barcelona, 08036
XAVIER FREIXA, MD, 34932275519, FREIXA@CLINIC.UB.ES
MARCO HERNANDEZ, MD, 34932275519, MHERNANE@CLINIC.UB.ES
About this study
Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac resynchronization therapy (CRT) has been shown to be effective in patients with dilated cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical improvement and reduced mortality. Importantly, 38% of patients with clinical indication for CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent predictor of no clinical response. In these patients, surgical FMR correction is frequently turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with the MitraClip system has demonstrated promising results in patients with dilated cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2, Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective nature of the study and the subsequent selection biases were however major limitations that impeded solid conclusions. The objective of the present study is to assess the efficacy and safety of the MitraClip system in non-responders to CRT and FMR ≥2.
Read the detailed description
STUDY HYPOTHESIS:
In patients with no response to CRT and significant FMR (grade ≥2, 100%), the MitraClip system will be associated with improved functional class, LVEF recovery and reduced LV volumes. To our knowledge, no registered randomized studies with a similar design are being conducted.
MAIN OBJECTIVE:
To compare the efficacy and safety of optimal medical treatment and MitraClip versus optimal medical treatment alone (control) in non-responders to CRT and symptomatic FMR ≥2.
- Conditions
- MITRAL REGURGITATION
- Being tested
- MITRACLIP
- Keywords
- MITRAL REGURGITATION
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITRACLIPDevice
MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | OPTIMIZED MEDICAL TREATMENT |
| DEVICE | Active comparator | MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM + OPTIMIZED MEDICAL TREATMENT Receives: Device: MITRACLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without adverse events related with the therapy and clinical improvement
Number of participants without adverse events related with the therapy (stroke, device embolization, emergent surgery/pericardiocentesis or procedural related mortality) and clinical improvement defined by improvement >10% in 6 min-walking test compared to the baseline situation and no readmissions for heart failure, heart transplantation or mortality.
SAFETY Definition: Stroke, device embolization, emergent surgery/pericardiocentesis and procedural related mortality.
Measured: 1 YEAR CLINICAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
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 MITRAL REGURGITATIONStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mitraclip versus control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, DR. XAVIER FREIXA, Hospital Clinic of Barcelona
- Investigators
- XAVIER FREIXA, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592889
- Sponsor's protocol ID
- MITRA-CRT
- Acronym
- MITRA-CRT
- Status last verified
- Feb 2017
- First submitted
- 22 Oct 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Freixa X, Tolosana JM, Cepas-Guillen PL, Hernandez-Enriquez M, Sanchis L, Flores-Umanzor E, Farrero M, Andrea R, Roque M, Carretero MJ, Regueiro A, Brugaletta S, Rodes-Cabau J, Mont L, Sitges M, Sabate M, Castel MA. Edge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial. Circ Heart Fail. 2022 Dec;15(12):e009501. doi: 10.1161/CIRCHEARTFAILURE.121.009501. Epub 2022 Sep 20. No abstract available.
PubMed 36124767
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (MitraClip in Non-Responders to Cardiac Resynchronization Therapy)
- ClinicalTrials.gov ID
- NCT02592889
- Acronym / sponsor ID
- MITRA-CRT / MITRA-CRT
- Conditions
- MITRAL REGURGITATION
- Keywords
- MITRAL REGURGITATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- 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.
Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac resynchronization therapy (CRT) has been shown to be effective in patients with dilated cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical improvement and reduced mortality. Importantly, 38% of patients with clinical indication for CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent predictor of no clinical response. In these patients, surgical FMR correction is frequently turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with the MitraClip system has demonstrated promising results in patients with dilated cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2, Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective nature of the study and the subsequent selection biases were however major limitations that impeded solid conclusions. The objective of the present study is to assess the efficacy and safety of the MitraClip system in non-responders to CRT and FMR ≥2.
Detailed description
STUDY HYPOTHESIS:
In patients with no response to CRT and significant FMR (grade ≥2, 100%), the MitraClip system will be associated with improved functional class, LVEF recovery and reduced LV volumes. To our knowledge, no registered randomized studies with a similar design are being conducted.
MAIN OBJECTIVE:
To compare the efficacy and safety of optimal medical treatment and MitraClip versus optimal medical treatment alone (control) in non-responders to CRT and symptomatic FMR ≥2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- mitraclip versus control
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –OPTIMIZED MEDICAL TREATMENT |
| DEVICE | Active comparator | Device: MITRACLIPMITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM + OPTIMIZED MEDICAL TREATMENT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CRT implanted between 6 months and 5 years before inclusion.
- Absence of clinical response to CRT defined by baseline NYHA 3 or NYHA 2 with a hospital admission for HF within the last 12 months.
- Adequate CRT therapy (correct stimulation in >98% heart beats).
- Correct position of the cardiac leads.
- Patients with atrial fibrillation will be included but balanced in both groups (the presence of AF is and independent factor of clinical response).
Key exclusion criteria (5 listed)
- Severe Renal Insufficiency (DFGe <30).
- Life expectancy < 1 year.
- Anatomical contraindication for MitraClip (in order to avoid selection biases, all patients must be Mitraclip candidates).
- Hemodynamic instability before inclusion defined by SBP <70 mmHg or the need of inotropic treatment within the previous 3 months.
- Inadequate treatment compliance or difficult follow-up.
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 |
|---|---|---|
| MITRACLIPMITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM | Device | DEVICE |
Primary outcome
Number of participants without adverse events related with the therapy and clinical improvement
Time frame: 1 YEAR CLINICAL
Number of participants without adverse events related with the therapy (stroke, device embolization, emergent surgery/pericardiocentesis or procedural related mortality) and clinical improvement defined by improvement >10% in 6 min-walking test compared to the baseline situation and no readmissions for heart failure, heart transplantation or mortality. SAFETY Definition: Stroke, device embolization, emergent surgery/pericardiocentesis and procedural related mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 36124767Freixa X, Tolosana JM, Cepas-Guillen PL, Hernandez-Enriquez M, Sanchis L, Flores-Umanzor E, Farrero M, Andrea R, Roque M, Carretero MJ, Regueiro A, Brugaletta S, Rodes-Cabau J, Mont L, Sitges M, Sabate M, Castel MA. Edge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial. Circ Heart Fail. 2022 Dec;15(12):e009501. doi: 10.1161/CIRCHEARTFAILURE.121.009501. Epub 2022 Sep 20. No abstract available.
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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.
XAVIER FREIXA, MD study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MITRACLIP in people with MITRAL REGURGITATION, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 8 inclusion and 5 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 23 Feb 2017. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 XAVIER FREIXA, MD (34932275519, FREIXA@CLINIC.UB.ES), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants without adverse events related with the therapy and clinical improvement (time frame: 1 YEAR CLINICAL). 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 NCT02592889, 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 23 Feb 2017.