NCT00478933

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,223 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Evaluate the positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia \<400 msec. 1. 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. 2. 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. 3. Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences\*. 4. Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences\*. 5. Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms. 6. 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.

Conditions

• Death, Sudden, Cardiac
• Ventricular Fibrillation
• Tachycardia
• Atrial Fibrillation
• Sick Sinus Syndrome

Interventions

Type	Name	Description
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	Blood sampling

Timeline

• Start date: 2007-02-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2007-05-25
• Last updated: 2025-07-02
• Results posted: 2017-11-22