Status:
NOT_YET_RECRUITING
Edge-to-edge Mitral Valve Repair in ATTR-CM
Lead Sponsor:
Medical University of Vienna
Conditions:
Mitral Regurgitation
ATTR-Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 regurgitatio...
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 ...
Eligibility Criteria
Inclusion
- 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 or tricuspid 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
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06075823
Start Date
January 1 2024
End Date
December 12 2028
Last Update
December 11 2023
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