Edge-to-edge Mitral Valve Repair in ATTR-CM | NCT06075823

NCT06075823

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional	Experimental	TEER + Optimal Medical Therapy	Device: TEER Other: Optimal Medical Therapy
Control	Active Comparator	Optimal Medical Therapy alone	Other: Optimal Medical Therapy

Name	Type	Description	Arm Group Labels	Other Names
TEER	Device	transcatheter edge-to-edge mitral valve repair for significant mitral regurgitation	Interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A hierarchical combination of all-cause mortality, cumulative frequency of cardiovascular-related hospitalization, change from baseline in NT-proBNP, and change from baseline in 6MWT through month 24	Each subject will be compared to every other subject within a stratum over outcomes of all-cause mortality (death due to any cause), cumulative frequency of cardiovascular-related hospitalizations (number of times a subject is hospitalized for cardiovascular-related causes), change from baseline in NT-proBNP, and change from baseline in the total distance walked in 6 minutes (distance in meters). The hierarchical approach with the Finkelstein-Schoenfeld test will be applied and the test recognizes the greater importance of the mortality endpoint. Scores are transformed to -1, 0, +1. The alternative hypothesis is a subject in the TEER+OMT group will have a greater score than a subject in the placebo group.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluate effects of TEER on quality of life (QoL) through Month 24	Change from Baseline to Month 24 as measured in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in subjects with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life (QoL). An Overall Summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, scores are transformed to a range of 0-100 using the formula, 100*[(mean of questions actually answered) - 1]/4, in which higher scores reflect better health status. The Overall Summary score is the mean of the domains scores, range from 0 to 100, in which higher scores reflect better health status.

Other Outcomes

Measure	Description	Time Frame
Effects of TEER on echocardiographic markers	Changes in forward stroke volume, ejection fraction, global longitudinal strain, etc.	24 months
Effects of TEER on invasive haemodynamics (in the TEER group only)

Eligibility Module

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 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

Name	Role	Phone	Extension	Email
Christian Nitsche, MD, PhD	Contact	0043 1 40400 46142		christian.nitsche@meduniwien.ac.at

Name	Affiliation	Role
Christian Nitsche, MD, PhD	Medical University of Vienna	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30280640	Background	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.
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