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National ARVC Data Registry and Bio Bank

NCT01804699 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2020-11-16

No results posted yet for this study

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

Conditions

  • Arrhythmogenic Right Ventricular Cardiomyopathy

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Andrew D Krahn, MD · University of British Columbia, Dept of Medicine, Head of Cardiology

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Canada

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804699 on ClinicalTrials.gov