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

Study acronym: MILLENNIAL
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Recruitment opened
    • Trial sites expanded: 0 → 10 locations
    • Enrollment target: 100 to 106
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 248 words
    • Publications: details revised at 4 of 4 entries
    • Collaborators expanded, about 4 words
  2. Eligibility criteria shortened, about 3 wordsv2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06075823
Lead Sponsor Medical University of Vienna
Collaborators: Austrian Science Fund (FWF)
Conditions
(from sponsor)		 Mitral Regurgitation, ATTR-Cardiomyopathy, Edge-to-Edge Mitral Valve Repair
Related terms Mitral Valve Insufficiency
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov