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Prolonged Monitoring to Detect Ventricular Arrhythmias in Presymptomatic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) Patients (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271816
Recruitment Status : Terminated (inadequate recruitment)
First Posted : January 7, 2011
Last Update Posted : January 3, 2014
Abbott Medical Devices
Information provided by (Responsible Party):
Andrew Krahn, Lawson Health Research Institute

Brief Summary:

Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition characterized by life threatening heart racing, presenting with palpitations, cardiac arrest (collapse requiring an ambulance) or sudden death. The disease affects the right ventricle, the part of the heart that pumps blood to the lungs. ARVC is diagnosed with a wide range of tests that focus on the pumping function and the electrical signals from the right ventricle. These factors are summarized in a score that forms the ARVC Task Force Criteria. Genetic testing has identified 5 different genes that lead to ARVC, which are detected in about 60% of patients with ARVC. This allows doctors to test family members of the patient with ARVC to determine if they are at risk of developing the condition. Currently, family members undergo testing that includes imaging and electrical tests such as a 24-hour monitor to determine if they have evidence of ARVC. With increasing frequency, family members are found to have the gene that may lead to ARVC, but little or no evidence that their hearts are affected. This may be because the family member is too young to develop the condition, or that other factors that we do not understand have protected them from developing it.

The PREPARE study will study 100 patients that carry a gene that can lead to ARVC, but do not have anything more than minor evidence that the condition is present. These patients will not have heart racing on their initial 24-hour monitor. These patients will undergo long term monitoring with an implanted heart monitor that is inserted with a minor surgical procedure, which will detect abnormal heart rhythms that may provide a clue that heart racing from ARVC is present that is not detected with a 24-hour monitor that is performed on an annual basis (St. Jude Confirm implantable loop recorder). These patients will be enrolled in 10 adult and pediatric centers across Canada, and followed for 3 years after their heart monitor is implanted. If heart racing is detected, patients will discuss these results with their doctor to discuss what it means to them.

Condition or disease
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prolonged Monitoring to Detect Ventricular Arrhythmias in Presymptomatic ARVC Patients
Study Start Date : December 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Presymptomatic ARVC gene carriers
ARVC gene positive patients without manifest ARVC after standard screening clinical testing.

Primary Outcome Measures :
  1. Detection of ≥8 beats of wide QRS complex tachycardia considered ventricular tachycardia (HR>120 bpm*) by the ILR [ Time Frame: 3 year monitoring follow-up ]
    * an algorithm to determine the ventricular tachycardia detection rate

Secondary Outcome Measures :
  1. Comparison of ventricular arrhythmia burden between routine [ Time Frame: 3 year monitoring follow-up ]
    * an algorithm to determine the ventricular tachycardia detection rate

  2. Change in 2010 Task Force Criteria Score from enrollment to 3-year follow-up. [ Time Frame: 3 year monitoring follow-up ]
  3. Detection of ≥30 seconds of wide QRS complex tachycardia considered ventricular tachycardia (HR>120 bpm*). [ Time Frame: 3 year monitoring follow-up ]
  4. Proportion of patients that go on to receive an ICD [ Time Frame: 3 year monitoring follow-up ]
  5. Proportion of patients that develop symptomatic sustained ventricular tachycardia [ Time Frame: 3 year monitoring follow-up ]
  6. Proportion of patients that develop sustained ventricular tachycardia, cardiac arrest or sudden death [ Time Frame: 3 year monitoring follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ARVC gene carriers with minimal or no evidence of being clinically affected

Inclusion Criteria:

  1. Identification of a pathogenic mutation† categorized as associated or probably associated with ARVC
  2. Failure to meet definite revised Task Force Criteria for ARVC. Mutation carriers by definition have a major criterion, so included patients may have 1 minor criteria, but would meet Task Force Criteria for ARVC with 2 minor criteria or 1 major criterion.
  3. < 200 PVCs / hour on screening Holter monitor
  4. Age > 2 years

Exclusion Criteria:

  1. Implantable device in place (pacemaker, ICD)
  2. Age < 2 years
  3. Mutation represents a variant of unknown significance with reasonable probability that it may not be disease causing
  4. Non-sustained ventricular tachycardia on screening Holter monitor (≥8 beats > 100 bpm) and/or ≥ 200 PVCs / hour
  5. Previous syncope or palpitations attributed to ARVC by the site investigator
  6. Meets definite revised Task Force Criteria for ARVC (≥2 minor criteria and/or ≥1 additional major criterion). These ARVC patients who do not have an implanted device (ICD or pacemaker) will be included in a parallel voluntary registry separate from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271816

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Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Abbott Medical Devices
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Principal Investigator: Andrew Krahn, MD FRCPC University of Western Ontario, Canada
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Responsible Party: Andrew Krahn, principal investigator, Lawson Health Research Institute Identifier: NCT01271816    
Other Study ID Numbers: R-10-532
17390 ( Other Identifier: REB )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014
Keywords provided by Andrew Krahn, Lawson Health Research Institute:
sudden death
loop recorder
Additional relevant MeSH terms:
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Arrhythmogenic Right Ventricular Dysplasia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities