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 range

2 Years

Sex

ALL

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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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Natural History of ARVC

Timeframe: Three years

Trial details

NCT IDNCT01804699

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08

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