Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-01
2028-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional
TEER + Optimal Medical Therapy
TEER
transcatheter edge-to-edge mitral valve repair for significant mitral regurgitation
Optimal Medical Therapy
optimal heart failure management of ATTR-CM
Control
Optimal Medical Therapy alone
Optimal Medical Therapy
optimal heart failure management of ATTR-CM
Interventions
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TEER
transcatheter edge-to-edge mitral valve repair for significant mitral regurgitation
Optimal Medical Therapy
optimal heart failure management of ATTR-CM
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Christian Nitsche
Principle Investigator
Principal Investigators
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Christian Nitsche, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Central Contacts
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References
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Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
Chacko L, Karia N, Venneri L, Bandera F, Passo BD, Buonamici L, Lazari J, Ioannou A, Porcari A, Patel R, Razvi Y, Brown J, Knight D, Martinez-Naharro A, Whelan C, Quarta CC, Manisty C, Moon J, Rowczenio D, Gilbertson JA, Lachmann H, Wechelakar A, Petrie A, Moody WE, Steeds RP, Potena L, Riefolo M, Leone O, Rapezzi C, Hawkins PN, Gillmore JD, Fontana M. Progression of echocardiographic parameters and prognosis in transthyretin cardiac amyloidosis. Eur J Heart Fail. 2022 Sep;24(9):1700-1712. doi: 10.1002/ejhf.2606. Epub 2022 Jul 27.
Nitsche C. Echocardiographic tracking of transthyretin cardiomyopathy: which parameters matter the most? Eur J Heart Fail. 2022 Sep;24(9):1713-1715. doi: 10.1002/ejhf.2639. Epub 2022 Aug 12. No abstract available.
Other Identifiers
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1830/2023
Identifier Type: -
Identifier Source: org_study_id