No phaseRecruitingAge-related condition
Edge-to-edge Mitral Valve Repair in ATTR-CM (MILLENNIAL)
Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis
- Sponsor
- Medical University of Vienna (Academic or other)
- Enrolment
- 106 planned
- Conditions
- Mitral Regurgitation; ATTR-Cardiomyopathy; Edge-to-Edge Mitral Valve Repair
- Interventions
- TEER; Optimal Medical Therapy
- Ages
- adults, older adults
- Registry
- NCT06075823
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Hierarchical composite of all-cause mortality, cumulative frequency of unplanned cardiovascular-related hospitalizations, change from baseline in 6-minute walk distance, and change from baseline in KCCQ Overall Summary score through month 12
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered