NCT01822145UnknownNot Applicable
PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
Princess Margaret Hospital, Hong Kong1 site in 1 country60 target enrollmentStarted: March 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- ICD-derived T-wave alternans amplitude before ICD shock
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ngai Yin Chan
Principal investigator
Princess Margaret Hospital, Hong Kong
Study Sites (1)
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