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NCT01822145 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

— PREDICT-ICDS  

Official title:
PREDICTion of Implantable-Cardioverter Defibrillator Shock Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01822145
Other study ID # PREDICTICDS01
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2013
Last updated September 3, 2015
Start date March 2013
Est. completion date January 2016

Study information
Verified date September 2015
Source Princess Margaret Hospital, Hong Kong
Contact Ngai Yin Chan, MBBS
Phone 852 2990 1111
Email ngaiyinchan@yahoo.com.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• ICD

Locations
Country Name City State
China Princess Margaret Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Princess Margaret Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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