Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-08 @ 10:26 AM
Study NCT ID:
NCT00478933
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2007-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
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 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.
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.
Study Oversight
Has Oversight DMC:
False
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?: