A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data

NCT01822145 — Unknown, 60 participants, Princess Margaret Hospital, Hong Kong

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PREDICTion of Implantable-Cardioverter Defibrillator Shock Study

RegistryNCT01822145, acronym PREDICT-ICDS
StatusUnknown
Study typeObservational
Enrollment60 (Estimated)
SponsorPrincess Margaret Hospital, Hong Kong (Other gov)
ConditionsSudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
InterventionsICD (Device)
Datesstart 2013-03-01, primary completion 2016-01-01 (estimated), completion 2016-01-01 (estimated), first posted 2013-04-02, last updated 2015-09-04
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Sudden Cardiac Arrest All trials for Ventricular Tachycardia All trials of ICD

-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

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+Arms and interventions

ArmTypeInterventionsDescription
ICD recipientsDevice: ICDICD recipients with documented cardiac arrest or ventricular arrhythmias
  • ICD (Device)

+Outcome measures

Primary outcomes

  • ICD-derived T-wave alternans amplitude before ICD shock [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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Princess Margaret HospitalHong KongChinaRecruiting

+Investigators