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Clinical Trials/NCT01822145
NCT01822145
Unknown
N/A

PREDICTion of Implantable-Cardioverter Defibrillator Shock Study

Princess Margaret Hospital, Hong Kong1 site in 1 country60 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sudden Cardiac Arrest
Sponsor
Princess Margaret Hospital, Hong Kong
Enrollment
60
Locations
1
Primary Endpoint
ICD-derived T-wave alternans amplitude before ICD shock
Last Updated
10 years ago

Overview

Brief Summary

The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
January 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Princess Margaret Hospital, Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Ngai Yin Chan

Principal investigator

Princess Margaret Hospital, Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Age ≧ 18 and ≦ 80
  • Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
  • Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
  • Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
  • Patients who are compliant to CareLink follow-up

Exclusion Criteria

  • Patients who are pregnant
  • Patients who are incapable of giving consent to the study
  • Patients who have a life-expectancy of less than 2 years

Outcomes

Primary Outcomes

ICD-derived T-wave alternans amplitude before ICD shock

Time Frame: 6 months

The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude

Study Sites (1)

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