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The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

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ClinicalTrials.gov Identifier: NCT02291393
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief Summary:
The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.

Condition or disease Intervention/treatment Phase
Arrhythmogenic Right Ventricular Cardiomyopathy Device: 80 lead ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of High Density Surface Cardiac Electrographic Mapping in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy :A Pilot Study
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Patient
Patients with previously confirmed Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Device: 80 lead ECG
Healthy volunteers
Aged and gender matched healthy controls.
Device: 80 lead ECG



Primary Outcome Measures :
  1. QRS wave dispersion in an ECG [ Time Frame: 5 minutes ]
    The difference in QRS wave dispersion between the right and left ventricular leads



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic

Exclusion Criteria:

  • Inability to consent
  • Pacing dependent patients
  • Other concomitant cardiag disease e.g. coronary artery disease
  • Atrial fibrillation

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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02291393     History of Changes
Other Study ID Numbers: CD12/10936
12/YH/0346 ( Other Identifier: Research Ethics Committee )
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Cardiomyopathies
Arrhythmogenic Right Ventricular Dysplasia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities