NCT06075823 Edge-to-edge Mitral Valve Repair in ATTR-CM
| NCT ID | NCT06075823 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2024-01-01 with a primary completion date of 2027-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Christian Nitsche, MD, PhD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT06075823 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06075823 currently recruiting?
Yes, NCT06075823 is actively recruiting participants. Contact the research team at christian.nitsche@meduniwien.ac.at for enrollment information.
Where is the NCT06075823 trial being conducted?
This trial is being conducted at Graz, Austria, Linz, Austria, Sankt Pölten, Austria, Vienna, Austria and 6 additional locations.
Who is sponsoring the NCT06075823 clinical trial?
NCT06075823 is sponsored by Medical University of Vienna. The principal investigator is Christian Nitsche, MD, PhD at Medical University of Vienna. The trial plans to enroll 106 participants.