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

• Conditions: Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Arrest
• Interventions: Device: ICD

• Registration Number: NCT01822145
• Lead Sponsor: Princess Margaret Hospital, Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICD recipients	ICD	ICD recipients with documented cardiac arrest or ventricular arrhythmias

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇳 Hong Kong, China