Mitral RegurgitationPRIME-MRNCT05332782
Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
An observational study of Mitral Regurgitation, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in 3 countries.
Trial summary
This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 2,000 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Mar 2022to 1 Jan 2026
- 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: Consecutive patients undergoing transcatheter edge-to-edge repair for primary mitral regurgitation
Who may be able to join
- clinically significant primary mitral regurgitation
- patient underwent M-TEER
- echocardiography data at baseline, procedure and follow-up
- follow-up of at least 12 months
Who cannot join
- age under 18 years
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier de Bordeaux
Bordeaux
Thomas Modine, MD, PhD
- Recruiting
Université Lille, Inserm, Centre Hospitalier Universitaire de Lille
Lille
Augustin Coisne, MD
- Recruiting
University Hospital of Rennes, Centre Hospitalier de Rennes
Rennes
Erwan Donal, MD
Germany2 sites, 2 recruiting
- Recruiting
University Heart & Vascular Center Hamburg
Hamburg, 20246
Benedikt Koell, MD, +4915222815230, b.koell@uke.de
Sebastian Ludwig, MD
- Recruiting
Klinikum der Universität München
Munich
Jörg Hausleiter, MD
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Azeem Latib, MD
Andrea Scotti, MD
About this study
This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| M-TEER | Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Incidence of death from any cause.
Measured: 12 months
Cardiovascular mortality
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Measured: 12 months
Rehospitalization for congestive heart failure
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Measured: 12 months
Re-do mitral valve procedure
Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.
Measured: 12 months
Secondary outcomes (4)
Residual mitral regurgitation
Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge.
Measured: up to 30 days
Residual mitral regurgitation
Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at 1-year follow-up.
Measured: 12 months
MVARC (Mitral Valve Academic Research Consortium) Technical success
All of the following must be present:
- Absence of procedural mortality
- Successful access, delivery, and retrieval
- Successful deployment and correct positioning of the first device
- Freedom from emergency surgery or reintervention related to the device or access procedure
Measured: 1 day (at exit from the catheterization laboratory)
Functional success
If one of the following is present:
- Residual mitral regurgitation ≤2+
- Effective regurgitant orifice area ≤15 mm2
- Transmitral gradient <5 mmHg
Measured: 1 day (at exit from the catheterization laboratory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (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.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Kalbacher, MD, Principal investigator, University Heart & Vascular Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332782
- Sponsor's protocol ID
- PRIME-MR
- Acronym
- PRIME-MR
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2022
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
- ClinicalTrials.gov ID
- NCT05332782
- Acronym / sponsor ID
- PRIME-MR / PRIME-MR
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 18 Apr 2022 (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 multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M-TEER | – | –Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing transcatheter edge-to-edge repair for primary mitral regurgitation
Key inclusion criteria (4 listed)
- clinically significant primary mitral regurgitation
- patient underwent M-TEER
- echocardiography data at baseline, procedure and follow-up
- follow-up of at least 12 months
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 12 months
Incidence of death from any cause.
Cardiovascular mortality
Time frame: 12 months
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Rehospitalization for congestive heart failure
Time frame: 12 months
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Re-do mitral valve procedure
Time frame: 12 months
Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.
4 secondary outcomes
Residual mitral regurgitation
Time frame: up to 30 days
Residual mitral regurgitation
Time frame: 12 months
MVARC (Mitral Valve Academic Research Consortium) Technical success
Time frame: 1 day (at exit from the catheterization laboratory)
Functional success
Time frame: 1 day (at exit from the catheterization laboratory)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- 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.
Daniel Kalbacher, MD principal investigator
University Heart & Vascular Center Hamburg
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in 3 countries.
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 1 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedikt Koell, MD (+4915222815230, b.koell@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months). 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?
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 18 Apr 2022.