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Clinical Trial 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 Alternans for their association with arrhythmic events.


Clinical Trial 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 patients to receive an implantable cardiac defibrillator (ICD). The successful accomplishment of this goal would serve as the basis for future work on a specific diagnostic test that can be used to assess risks of threatening arrhythmias in order to quality patients for implantation of an ICD.

- to identify single nucleotide polymorphisms (SNPs) that can be used to identify individuals in need of an ICD.

The secondary objectives involve more detailed analysis to search for potentially unidentified genetic markers of risk for SCD.

1. to identify genes associated with SCD susceptibility.

2. to identify risk factors associated with SCD as found in the case report form (CRF).

3. to correlate SNPs with co-morbidities in the subjects as found in the CRF information.

4. to study the association between parameters derived from Holter recordings and predictors of life-threatening arrhythmias. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00664807
Study type Observational
Source Medtronic Corporate Technologies and New Ventures
Contact
Status Completed
Phase Phase 4
Start date April 2008
Completion date May 2009

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