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A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data (PREDICT-ICDS)

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ClinicalTrials.gov Identifier: NCT01822145
Recruitment Status : Unknown
Verified September 2015 by Ngai Yin Chan, Princess Margaret Hospital, Hong Kong.
Recruitment status was:  Recruiting
First Posted : April 2, 2013
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong

Tracking Information
First Submitted Date March 24, 2013
First Posted Date April 2, 2013
Last Update Posted Date September 4, 2015
Study Start Date March 2013
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2013)
ICD-derived T-wave alternans amplitude before ICD shock [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01822145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data
Official Title PREDICTion of Implantable-Cardioverter Defibrillator Shock Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation
Condition
  • Sudden Cardiac Arrest
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Intervention Device: ICD
Study Groups/Cohorts ICD recipients
ICD recipients with documented cardiac arrest or ventricular arrhythmias
Intervention: Device: ICD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 27, 2013)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01822145
Other Study ID Numbers PREDICTICDS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
Study Sponsor Princess Margaret Hospital, Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Ngai Yin Chan, MBBS Princess Margaret Hospital, Canada
PRS Account Princess Margaret Hospital, Hong Kong
Verification Date September 2015