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Edge-to-edge Mitral Valve Repair in ATTR-CM

RecruitingNAAges 18 Years - anyAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. From a pathophysiological perspective, effective treatment of significant regurgitant volume and consecutive improvement of forward volume appears highly desirable in a condition with intrinsically low output. However, whether this translates into improved functional capacity, better quality of life, and better clinical outcomes compared to conservative heart failure management alone remains to be investigated.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria (all must be present) * Proven ATTR-CM * Significant symptomatic MR (3+ or 4+ by independent echocardiographic core laboratory assessment) * Subject has been adequately treated per applicable standards, including for coronary artery disease and heart failure (e.g., diuretics) * New York Heart Association (NYHA) functional class II, III, or ambulatory IV * Local heart team has determined that mitral valve surgery will not be offered as a treatment option, even if the subject is randomized to the control group * Left ventricular ejection fraction ≥20% * Anatomical feasibility for TEER as per discretion of the implanting investigator * Age 18 years or older * Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Exclusion criteria (all must be absent) * AL-associated cardiomyopathy * Aortic valve disease requiring surgery or transcatheter intervention * Severe right ventricular dysfunction * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER * Life expectancy \<12 months due to non-cardiac conditions * Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure * Echocardiographic evidence of intracardiac mass, thrombus or vegetation * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) * Active infections requiring current antibiotic therapy * Transesophageal echocardiography (TEE) is contraindicated or high risk * Pregnant or planning pregnancy within next 12 months * Currently participating in another investigational device study that has not reached its primary endpoint
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What it tests

  • TEER
  • Optimal Medical Therapy
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Where

10 sites
Medical University of Graz, Division of Cardiology
Graz, Austria
Ordensklinikum Linz Elisabethinen, Internal Medicine 2, Cardiology
Linz, Austria
University Hospital St. Pölten, Department of Internal Medicine 3
Sankt Pölten, Austria
Clinic Favoriten, 5th Medical Department, Cardiology
Vienna, Austria
Medical University of Vienna
Vienna, Austria
Hannover Medical School, Department of Cardiology and Angiology
Hanover, Germany
University Hospital Heidelberg, Department of Cardiology, Angiology and Respiratory Medicine
Heidelberg, Germany
LMU University Hospital, Department of Medicine I
München, Germany

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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