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

NCT ID: NCT01822145

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Sudden Cardiac Arrest Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICD recipients

ICD recipients with documented cardiac arrest or ventricular arrhythmias

ICD

Intervention Type DEVICE

Interventions

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ICD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ngai Yin Chan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ngai Yin Chan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ngai Yin Chan, MBBS

Role: CONTACT

852 2990 1111

Facility Contacts

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Ngai Yin Chan, MBBS

Role: primary

852 29901111

Other Identifiers

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PREDICTICDS01

Identifier Type: -

Identifier Source: org_study_id

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