DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients. (DISCOVERY)
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.
|Death, Sudden, Cardiac Ventricular Fibrillation Tachycardia Atrial Fibrillation Sick Sinus Syndrome||Device: Defibrillator, Dual Chamber ; Implantable Procedure: Blood sampling||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients.|
- Positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia <400 msec. [ Time Frame: 2 years ]
- Hospitalization, medical interventions, medication, surgery, additional diagnostics [ Time Frame: 2 years ]
- All Cause Mortality, Cardiac death and atrial fibrillation/flutter [ Time Frame: 2 years ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: ICD Therapy, blood sampling
Blood sampling Defibrillator, Dual Chamber ; Implantable
Device: Defibrillator, Dual Chamber ; Implantable
Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.Procedure: Blood sampling
Evaluate the positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia <400 msec.
- Evaluate the positive predictive value of Single Nucleotide Polymorphisms as predictor for death, cardiac death and atrial fibrillation/flutter in the genes GNB3, GNAS, GNAQ and other SNPs involving signal transduction components which impact on the activity of cardiac ion channels.
- Evaluate the best combination of genetic parameters, baseline data and follow-up data as predictor of primary endpoint, All cause Mortality, cardiac death and atrial arrhythmia.
- Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences*.
- Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences*.
- Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms.
Evaluate the frequency of pacing-parameter programming changes and the resulting medical consequences*.
- Medical consequences include: Hospitalization, medical interventions, medication, surgery, additional diagnostics and ICD-programming changes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478933
|Principal Investigator:||Domenico Corrado, MD||University of Padova, Italy|
|Principal Investigator:||Heiner Wieneke, MD||Universitätsklinikum Essen, Germany|