Edge-to-edge Mitral Valve Repair in ATTR-CM
Key facts
- Where
- Bergamo and Brescia, ItalySee the 2 sites
Where in Italy
- ASST Papa Giovanni XXIII, Cardiovascular DepartmentBergamo, ItalyNot yet recruiting
- ASST Spedali Civili di Brescia, CardiologyBrescia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT06075823
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis
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.
Inclusion: 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: Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure; Currently participating in another investigational device study that has not reached its primary endpoint; Aortic valve disease requiring surgery or transcatheter intervention; Hemodynamic instability requiring inotropic support or mechanical heart assistance; Life expectancy <12 months due to non-cardiac conditions; Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated); Active infections requiring current antibiotic therapy; AL-associated cardiomyopathy; Severe right ventricular dysfunction; Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Transesophageal echocardiography (TEE) is contraindicated or high risk; Pregnant or planning pregnancy within next 12 months.