Status:
COMPLETED
National ARVC Data Registry and Bio Bank
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Population Health Research Institute
Medtronic
Conditions:
Arrhythmogenic Right Ventricular Cardiomyopathy
Eligibility:
All Genders
2+ years
Brief 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 deat...
Detailed Description
BACKGROUND: Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is a familial condition characterized by onset of life threatening ventricular arrhythmias in early adulthood, presenting with ventr...
Eligibility Criteria
Inclusion
- Inclusion Requirements:
- 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
- A pathogenic mutation is a DNA alteration associated with ARVC/D that alters or is expected to alter the encoded protein in a significant way, is unobserved or rare in a large non-ARVC/D control population, and either alters or is predicted to alter the structure or function of the protein (by computational (in silico) predictions and/or functional validation in a biological model system) or has demonstrated linkage to the disease phenotype in a conclusive pedigree 4. Mutation carriers by definition have a single major Task Force criterion.
- EXCLUSION CRITERIA:
- Exclusion Requirements:
- 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
- Age \< 2 years
- Life expectancy less than 1 year
- Unable and/or unwilling to provide informed consent
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01804699
Start Date
January 1 2013
End Date
August 1 2020
Last Update
November 16 2020
Active Locations (16)
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1
Libin Cardiovascular Institute of Alberta, University of Calgary
Calgary, Alberta, Canada
2
BC Children's Hospital
Vancouver, British Columbia, Canada
3
University of British Columbia, St. Paul's Hospital
Vancouver, British Columbia, Canada
4
University of Victoria, Victoria Jubilee Hospital
Victoria, British Columbia, Canada