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AzTrials

Severe Mitral RegurgitationPRE-MITRANCT04913727

Prediction of Reverse Remodeling and Outcome in Patients With Severe Secondary Mitral Valve Regurgitation Undergoing Transcatheter Edge-to-edge Mitral Valve Repair

A study testing Cardiac magnetic resonance imaging before the procedure and Transcatheter mitral edge-to-edge repair. in people with Severe Mitral Regurgitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Mitral Regurgitation
What is being tested?
Cardiac magnetic resonance imaging before the procedure and Transcatheter mitral edge-to-edge repair.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSwitzerland
Study dates
4 Aug 2021to 30 Sep 2026
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

  • Patients with severe secondary MR characterized, according to the European guidelines and recommendations, by a regurgitant volume ≥30 mL/beat or an effective regurgitant orifice ≥20 mm².
  • Symptomatic patients with New York Heart Association Class ≥II.
  • Left ventricular ejection fraction between 15% and 50%.
  • Optimal standard of care therapy for heart failure according to investigator.
  • Not eligible for a mitral surgery intervention according to the Heart Team.
  • Patients who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.

Who cannot join

  • Participants younger than 18 years
  • Pregnancy or breastfeeding
  • Severe impaired renal function (GFR < 15 ml/min)
  • Patients with untreated severe concomitant valve disease (e.g. severe tricuspid valve regurgitation, aortic stenosis)
  • The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
  • The patient has contraindications to CMR, including: Implanted non-CMR conditional metallic implants, pacemaker, intracardiac defibrillator, neurostimulator, epicardial pacemaker leads, or any abandoned leads, ferromagnetic aneurysm clip, ferromagnetic halo device, cochlear implants, implanted infusion pumps or severe claustrophobia
  • The patient is clinically unstable or has stage D congestive heart failure or inability to lay flat for 60 minutes

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Cardiology, University Hospital Bern, Inselspital, Bern

    Bern, 3010

Other trials in Switzerland

About this study

The investigators' hypothesis is that CMR tissue characterization and myocardial function analysis acquired by CMR feature tracking technique predict reverse remodeling in patients with severe secondary mitral regurgitation (MR) undergoing transcatheter mitral edge-to-edge repair.

Read the detailed description

Diametrically opposed results of the COAPT- and the MITRA-FR trial have demonstrated the need for additional evidence in the field of transcatheter mitral edge-to-edge repair. Reverse left ventricular remodeling after treatment of severe secondary mitral regurgitation can indicate treatment response and is associated with positive outcomes.

However, so far it is reverse remodeling, respectively treatment response is difficult to predict, which complicates patient selection for mitral edge-to-edge repair. Previous studies have shown, that focal (late gadolinium enhancement (LGE)) but not diffuse myocardial fibrosis (T1 mapping and extracellular volume fraction (ECV)) burden quantification using CMR predicts reverse left ventricular remodeling following cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction (HFrEF). On the other hand, myocardial T1 mapping was predictive for beneficial left ventricular remodeling after long-term heart failure therapy. Furthermore, in patients with HFrEF, LGE is associated with clinical outcome and an incremental predictive value to left ventricular dimensions and function. However, as only 1/3 of HFrEF patients show LGE, subtle fibrosis might be missed. Recently the investigators have shown that different novel fibrosis detection techniques (naive T1 mapping, mean ECV and λGd being the delta of pre- and post T1 mapping and ECV calculation) all demonstrated strong association with outcome in patients with heart failure.

The investigators' hypothesis is that these markers (CMR tissue characterization and myocardial function analysis acquired by a CMR feature tracking) might also be helpful in predicting reverse remodeling after transcatheter mitral edge-to-edge repair. This project might help to understand the pathophysiology of the disease in patients with secondary mitral regurgitation, improve risk stratification in this clinical setting, and optimize selection of patients who benefit from transcatheter mitral edge-to-edge repair.

Being tested
Cardiac magnetic resonance imaging before the procedure, Transcatheter mitral edge-to-edge repair.
Keywords
Cardiac magnet resonance (CMR), Mitral Regurgitation, Transcatheter mitral edge-to-edge repair, MitraClip, CMR feature tracking, Parametric mapping
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.

  • Cardiac magnetic resonance imaging before the procedureDiagnostic test

    CMR image acquisition with previously mentioned analysis

  • Transcatheter mitral edge-to-edge repair.Procedure or surgery

    Included patients will undergo Transcatheter mitral edge-to-edge repair.

Study groups in NCT04913727
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients undergoing transcatheter mitral edge-to-edge repair in this single-arm study.
Receives: Diagnostic Test: Cardiac magnetic resonance imaging before the procedure; Procedure: Transcatheter mitral edge-to-edge repair.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients with reverse remodeling after 12 months

    Defined as ≥10% reduction in left ventricular end-diastolic volume in patients with successful MR reduction to grade 2+ or less 12 months after mitral edge-to-edge repair assessed by echocardiography.

    Measured: 12 months after mitral edge-to-edge repair

Secondary outcomes (10)

  1. Rate of patients with procedural and device success

    Procedural and device success as defined according to the criteria of the Mitral Valve Academic Research Consortium

    Measured: 24 months after mitral edge-to-edge repair

  2. Rate of patients with reverse remodeling after 6 and 24 months

    Reverse remodeling at 6 and 24 months, defined according to previously mentioned criteria.

    Measured: 6 and 24 months after mitral edge-to-edge repair

  3. Change of left ventricular sphericity index

    Echocardiographic assessment of LV sphericity index measured using the LV short/long axis dimension ratio in the end-diastolic four-chamber apical view.

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  4. Change in NT-proBNP levels

    Change in NT-proBNP levels as an indirect sign of changes in left ventricular filling pressure, fibrosis and reverse remodeling will be measured in clinically indicated follow-ups at different time points after the intervention.

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  5. All cause death

    Occurence of death from any cause

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  6. Cardiovascular death

    Occurence of death from cardiovascular reason

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  7. Rate of patients with heart-failure related hospitalization

    Hospitalizations for heart failure within the observation time will be systematically recorded.

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  8. Change in NYHA class

    Change in NYHA class ≥ +/- 1 compared to baseline NYHA-class before mitral edge-to-edge repair.

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

  9. Change in myocardial strain

    Clinically indicated follow-up imaging (CMR) will be analyzed by CMR feature tracking

    Measured: Within 24 months after mitral edge-to-edge repair

  10. Change in left ventricular ejection fraction

    Echocardiographic assessment of left ventricular ejection fraction measured according to biplane Simpson disk summation method.

    Measured: 6, 12 and 24 months after mitral edge-to-edge repair

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start4 Aug 2021
  3. Primary completion28 Feb 2025
  4. Study completion30 Sep 2026

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913727
Sponsor's protocol ID
2021-00704
Acronym
PRE-MITRA
Status last verified
Dec 2025
First submitted
27 May 2021
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.

    PubMed 30280640

  • Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

    PubMed 30145927

  • Praz F, Grasso C, Taramasso M, Baumbach A, Piazza N, Tamburino C, Windecker S, Maisano F, Prendergast B. Mitral regurgitation in heart failure: time for a rethink. Eur Heart J. 2019 Jul 14;40(27):2189-2193. doi: 10.1093/eurheartj/ehz222. No abstract available.

    PubMed 31005977

  • Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.

    PubMed 29025553

  • Grani C, Biere L, Eichhorn C, Kaneko K, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Incremental value of extracellular volume assessment by cardiovascular magnetic resonance imaging in risk stratifying patients with suspected myocarditis. Int J Cardiovasc Imaging. 2019 Jun;35(6):1067-1078. doi: 10.1007/s10554-019-01552-6. Epub 2019 Feb 12.

    PubMed 30756221

  • Grani C, Eichhorn C, Biere L, Kaneko K, Murthy VL, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Comparison of myocardial fibrosis quantification methods by cardiovascular magnetic resonance imaging for risk stratification of patients with suspected myocarditis. J Cardiovasc Magn Reson. 2019 Feb 28;21(1):14. doi: 10.1186/s12968-019-0520-0.

    PubMed 30813942

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac magnetic resonance imaging before the procedure and Transcatheter mitral edge-to-edge repair. in people with Severe Mitral Regurgitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 6 inclusion and 7 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 6 Nov 2026. 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 Switzerland. 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 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?

Rate of patients with reverse remodeling after 12 months (time frame: 12 months after mitral edge-to-edge repair). 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 NCT04913727, which also lists 6 linked publications.

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 6 Nov 2026.

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