Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
Completed
Conditions studied: Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
In brief
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 Alternans for their association with arrhythmic events.
Key facts
- Study ID
- NCT00664807
- Run by
- Medtronic Corporate Technologies and New Ventures
- People needed
- 1023
- Starts
- 2008-04-01
- Expected to finish
- 2009-05-01
- Last updated by the study team
- 2009-08-25
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 Inclusion Criteria:
- 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 Inclusion Criteria:
- 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
You may not qualify if…
- 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 Exclusion Criteria:
- The following criteria apply to control subjects only:
- Subject has had a potentially LTA documented on their ICD
- Subject was previously identified as having a LTD at any time in life
- Subject has had the memory on their ICD cleared at any time in the past three years.
Where it is running
- Arkansas Cardiology, PA — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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