NCT06075823

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

Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Severe mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

It is the aim of this trial to investigate the effectiveness of TEER therapy in patients with proven ATTR-CM and concomitant significant MR as compared to medical therapy alone. Effectiveness will be tested via hard clinical outcomes, biomarkers, functional capacity, and quality of life.

Conditions

• Mitral Regurgitation
• ATTR-Cardiomyopathy
• Edge-to-Edge Mitral Valve Repair

Interventions

Type	Name	Description
DEVICE	TEER	transcatheter edge-to-edge mitral valve repair for significant mitral regurgitation
OTHER	Optimal Medical Therapy	optimal heart failure management of ATTR-CM

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-12-12
• Completion: 2028-12-12
• First posted: 2023-10-10
• Last updated: 2023-12-11