National ARVC Data Registry and Bio Bank (NCT01804699) | Clinical Trial Compass
CompletedNot Applicable
National ARVC Data Registry and Bio Bank
Canada1,500 participantsStarted 2013-01
Plain-language summary
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition that may cause life threatening irregular heart rhythms that often manifest as unexpected cardiac arrest or sudden death in early adulthood. The condition is difficult to diagnose and often is not noticed until a family member suffers a cardiac arrest or death.
The Canadian National ARVC registry will collect data from Inherited Heart Rhythm Clinics across Canada.
STUDY OBJECTIVES:
Primary:
1. To determine the natural history of ARVC (short/intermediate term), including risk of symptomatic arrhythmias and sudden death, for patients with the phenotype and those gene positive patients without phenotype evidence of disease.
2. To understand risk factors for sudden death/appropriate ICD use in ARVC, including test characteristics/performance and their relationship to outcomes (ECG, Holter, signal averaged ECG, loop recorders, imaging, voltage mapping, T wave alternans, cardiac biopsy and biomarkers).
3. To establish a phenotype genotype correlation, including comparison of patients with disease causing mutations, variants of unknown significance (VUS) and Task Force Criteria (TFC) positive, gene negative patients
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
✓. 2010 Revised Task Force Criteria positive patients (please refer to Appendix 3.0)
✓. 2010 Revised Task Force Criteria borderline patients
✓. Disease causing ARVC pathogenic mutation\* carriers with no TFC criteria for ARVC
✓. Variants of unknown significance carriers with ≥1 minor TFC criterion
✓. Age ≥ 2 years
✓. First-degree relatives of 2010 Revised Task Force Criteria positive or borderline patients
✓. Able and willing to provide informed consent, or has a parent/guardian able and willing to provide informed consent and/or able to sign an assent form
Exclusion criteria
✕. Known condition that mimics ARVC - sarcoidosis (biopsy proven or with lung involvement), familial dilated cardiomyopathy not compatible with an ARVC variant, hypertrophic cardiomyopathy
✕. Known inherited condition that predisposes to sudden death - Long or Short QT Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia and Brugada Syndrome