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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00478933 |
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.
Condition | Intervention | Phase |
---|---|---|
Death, Sudden, Cardiac Ventricular Fibrillation Tachycardia Atrial Fibrillation Sick Sinus Syndrome |
Device: Defibrillator, Dual Chamber ; Implantable Procedure: Blood sampling |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-Arrhythmia in ICD Patients. |
Estimated Enrollment: | 1300 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
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 frequency of pacing-parameter programming changes and the resulting medical consequences*.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with syndromes known to be associated with ion channel pathologies such as:
Contact: Marc D Messier, Ph.D. | marc.messier@medtronic.com | |
Contact: Antoine Cuijpers, M.Sc. | antoine.cuijpers@medtronic.com |
Germany | |
Universitätsklinikum Essen | Recruiting |
Essen, Germany, 45122 | |
Contact: Heiner Wieneke, MD heiner.wieneke@gmx.de | |
Principal Investigator: Heiner Wieneke, MD |
Principal Investigator: | Domenico Corrado, MD | University of Padova, Italy |
Principal Investigator: | Heiner Wieneke, MD | Universitätsklinikum Essen, Germany |
Responsible Party: | MEDTRONIC Bakken Research Center B.V. ( Marc Messier , Outcomes Study Manager, Clin Outcomes Research and Biometry ) |
Study ID Numbers: | DISCOVERY |
Study First Received: | May 23, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00478933 History of Changes |
Health Authority: | Germany: Ethics Commission |
Arrhythmia Ventricular Atrial Tachycardia Fibrillation |
Flutter GNB3 GNAS GNAQ |
Death Heart Diseases Tachycardia Arrhythmia, Sinus Heart Arrest Paroxysmal Ventricular Fibrillation Heart Block |
Death, Sudden Death, Sudden, Cardiac Atrial Fibrillation Sick Sinus Syndrome Ventricular Fibrillation Arrhythmias, Cardiac |
Death Disease Heart Diseases Tachycardia Arrhythmia, Sinus Heart Arrest Pathologic Processes Heart Block |
Syndrome Death, Sudden Cardiovascular Diseases Atrial Fibrillation Death, Sudden, Cardiac Sick Sinus Syndrome Ventricular Fibrillation Arrhythmias, Cardiac |