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

NCT04913727 | Recruiting

• 1 other identifier: 2021-00704
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Mitral Regurgitation

Keywords

Cardiac magnet resonance (CMR); Mitral Regurgitation; Transcatheter mitral edge-to-edge repair; MitraClip; CMR feature tracking; Parametric mapping

Outcome Measures

Primary Outcomes (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.

  12 months after mitral edge-to-edge repair

Secondary Outcomes (10)

• Rate of patients with procedural and device success

  24 months after mitral edge-to-edge repair

• Rate of patients with reverse remodeling after 6 and 24 months

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

• Change of left ventricular sphericity index

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

• Change in NT-proBNP levels

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

• All cause death

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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Patients undergoing transcatheter mitral edge-to-edge repair in this single-arm study.

Diagnostic Test: Cardiac magnetic resonance imaging before the procedure; Procedure: Transcatheter mitral edge-to-edge repair.

Interventions

Cardiac magnetic resonance imaging before the procedure DIAGNOSTIC_TEST

CMR image acquisition with previously mentioned analysis

Treatment Arm

Transcatheter mitral edge-to-edge repair. PROCEDURE

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Basel, Switzerland: collaborator
• Cardiocentro Ticino: collaborator
• Triemli Hospital: collaborator

Study Sites (1)

Department of Cardiology, University Hospital Bern, Inselspital, Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (6)

• 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.

  PMID: 30280640 RESULT

• 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.

  PMID: 30145927 RESULT

• 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.

  PMID: 31005977 RESULT

• 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.

  PMID: 29025553 RESULT

• 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.

  PMID: 30756221 RESULT

• 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.

  PMID: 30813942 RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Christoph MD Gräni, PHD

  Department of Cardiology, University Hospital Bern, Inselspital, Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph MD Gräni, PHD

CONTACT

+41 31 632 4508; christoph.graeni@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 4, 2021
• Study Start: August 4, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)