A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data
PREDICT-ICDS
PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 4, 2015
September 1, 2015
2.8 years
March 24, 2013
September 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ICD-derived T-wave alternans amplitude before ICD shock
The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude
6 months
Study Arms (1)
ICD recipients
ICD recipients with documented cardiac arrest or ventricular arrhythmias
Interventions
Eligibility Criteria
ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Hospital
Hong Kong, 999077, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ngai Yin Chan, MBBS
Princess Margaret Hospital, Canada
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 24, 2013
First Posted
April 2, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
September 4, 2015
Record last verified: 2015-09