Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478933
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2007-05-23
Brief Title:
DISCOVERY Diagnostic Data and Genetic Polymorphisms in ICD Patients
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCOVERY
Brief 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
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 fibrillationflutter 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
1 Evaluate the positive predictive value of Single Nucleotide Polymorphisms as predictor for death cardiac death and atrial fibrillationflutter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None