Status:
COMPLETED
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
Lead Sponsor:
Medtronic Corporate Technologies and New Ventures
Conditions:
Death, Sudden, Cardiac
Ventricular Fibrillation
Eligibility:
All Genders
40+ years
Brief Summary
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alt...
Detailed Description
The primary objective is to establish the role of genetics in life-threatening arrhythmias leading to sudden cardiac death (SCD) and the potential utility of genetic markers in risk stratification of ...
Eligibility Criteria
Inclusion
- The following criteria apply to all subjects:
- Subject has an ICD or CRT ICD implanted
- Subject must be on optimal medical therapy
- Subject is a Caucasian with all 4 grandparents believed to be Caucasian
- Subject has had a myocardial infarction (MI) prior to ICD implantation
- Subject is willing and able to comply with the study protocol
- Subject is willing and able to sign and date the study Informed Consent and HIPAA Authorization (US)
- Case
- The following criteria apply to case subjects only:
- Subject is at least 40 years of age at time of ICD implantation
- Subject has at least one documented life-threatening arrhythmia (LTA) on their ICD that can transferred as a save-to-disk or has had an LTA documented in their medical history. LTA is defined as a true VT/VF episode with cycle length less than or equal to 400ms that was terminated by the device.
- Control
- The following criteria apply to control subjects only:
- Subject is currently at least 70 years of age
- Subject has haad currently implanted Medronic ICD for a minimum of three years
Exclusion
- The following criteria apply to all subjects:
- Subject has received a bone marrow or heart transplant at any time
- Subject has a previously identified cause for arrhythmias (Brugada, LQT, HCM)
- Control
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT00664807
Start Date
April 1 2008
End Date
May 1 2009
Last Update
August 25 2009
Active Locations (1)
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1
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72205