Ventricular Fibrillation Clinical Trial
Official title:
The Leiden Nonischemic Cardiomyopathy Study
Rationale: Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major
cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that
effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms of
VA in NICM may allow more effective, individualized and substrate-based therapies to be
developed. In addition, risk stratification in NICM needs to be improved so that therapies
can be allocated more efficiently.
Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and
electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA
based on the identified substrate. 2) To improve risk stratification for VA and sudden
cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression
in NICM.
Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow
more effective, individualized and substrate-based therapies to be developed.
Study design: A prospective cohort study.
Study population: The study population will consist of three groups (A, B and C): NICM
patients with documented VA, suspected VA or intermediate to high risk for VA (according to
established criteria) who are not referred for cardiac surgery (group A), NICM patients with
documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group
B) and a control group consisting of patients without NICM who are referred for cardiac
surgery (group C).
Evaluation: All patients will be evaluated according to current standards for patients with
NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and
contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional
recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac
venous and peripheral venous) for collagen turnover markers will be taken from all patients.
123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and
endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be
performed in group B and C.
Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative
electrophysiologic study will be performed in patients with subepicardial late enhancement on
MRI or induced VA suspected for an subepicardial origin.
Main study parameters/endpoints: The main study parameters are extent, location and pattern
of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of
VA, type of induced VA, spontaneous VA and type of spontaneous VA.
n/a
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