Mitral RegurgitationNCT03107455
MitraClip in Acute Mitral Regurgitation
An observational study of Mitral Regurgitation and Acute Myocardial Infarction, run by Fundación Investigación Sanitaria en León.
Trial summary
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Acute Myocardial Infarction
- What is being tested?
- MitraClip
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2021
- Phase
- Observational
- 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
Study population: Patients experiencing transmural myocardial infarction in the previous 4 weeks and developing secondary mitral regurgitation not responding to medical therapy.
Who may be able to join
- Patient ≥ 18 year-old
- Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations).
- Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock.
- Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices
- Considered by heart team at high risk for conventional surgery
Who cannot join
- Anatomy not suitable for MitraClip implantation
- Technical contraindication for access to left atrium
- Patient candidate for emergent heart transplant
- Uncontrolled infection
About this study
Official title: European Registry of MitraClip in Acute Myocardial Infarction
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.
- Conditions
- Mitral Regurgitation, Acute Myocardial Infarction
- Being tested
- MitraClip
- Keywords
- MitraClip, Acute mitral regurgitation, Acute myocardial infarction
- 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
MitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary end point
death from cardiac causes, readmission due to heart failure and mitral regurgitation >2+
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2019
- Study completion1 Dec 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Investigación Sanitaria en León
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Felipe Fernandez Vazquez, Fundación Investigación Sanitaria en León
- Investigators
- Rodrigo Estevez-Loureiro, PhD, Principal investigator, University Hospital LeonCarmelo Grasso, PhD, Principal investigator, Ferraroto Hospital CataniaJan Van der Heijden, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107455
- Sponsor's protocol ID
- EREMMI
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry of MitraClip in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03107455
- Acronym / sponsor ID
- EREMMI
- Conditions
- Mitral Regurgitation, Acute Myocardial Infarction
- Keywords
- MitraClip, Acute mitral regurgitation, Acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación Investigación Sanitaria en LeónUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 Apr 2017 (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.
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing transmural myocardial infarction in the previous 4 weeks and developing secondary mitral regurgitation not responding to medical therapy.
Key inclusion criteria (5 listed)
- Patient ≥ 18 year-old
- Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations).
- Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock.
- Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices
- Considered by heart team at high risk for conventional surgery
Key exclusion criteria (4 listed)
- Anatomy not suitable for MitraClip implantation
- Technical contraindication for access to left atrium
- Patient candidate for emergent heart transplant
- Uncontrolled infection
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 |
|---|---|---|
| MitraClipMitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet | Device | – |
Primary outcome
Composite primary end point
Time frame: 6 month
death from cardiac causes, readmission due to heart failure and mitral regurgitation >2+
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 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
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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.
Rodrigo Estevez-Loureiro, PhD principal investigator
University Hospital Leon
Carmelo Grasso, PhD principal investigator
Ferraroto Hospital Catania
Jan Van der Heijden, PhD principal investigator
St. Antonius Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Acute Myocardial Infarction, run by Fundación Investigación Sanitaria en León.
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 5 inclusion and 4 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite primary end point (time frame: 6 month). 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 16 Mar 2022.