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Clinical Trials/NCT02560844
NCT02560844
Completed
Not Applicable

Cardiomyopathy Arrhythmia Risk Evaluation

University Health Network, Toronto1 site in 1 country164 target enrollmentJuly 2015
ConditionsCardiomyopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy
Sponsor
University Health Network, Toronto
Enrollment
164
Locations
1
Primary Endpoint
Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

Detailed Description

Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • cardiomyopathy, primary prevention ICD

Exclusion Criteria

  • brady-pacing requirement

Outcomes

Primary Outcomes

Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks

Time Frame: 2 years

Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

Study Sites (1)

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