N/A
Completed N=1,223
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
Death, Sudden, Cardiac · ventricular fibrillation · Tachycardia · Atrial Fibrillation
Source: ClinicalTrials.gov NCT00478933 ↗
Enrolled (actual)
1,223
Serious AEs
23.1%
Results posted
Nov 2017
Primary outcomePrimary: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype — 63; 136; 98 participants with VT < 400 msec
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype |
63; 136; 98 | — |
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype |
103; 136; 59 | — |
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype |
145; 123; 29 | — |
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype |
85; 143; 69 | — |
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype |
253; 42; 2 | — |
| PRIMARY Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype |
268; 29; 0 | — |
| PRIMARY Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype |
135; 136; 26 | — |
| SECONDARY Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics |
— | — |
| SECONDARY All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter |
— | — |
Eligibility Criteria
Inclusion Criteria
- Implantation of a market approved Medtronic Dual-chamber ICD with long term clinical trends Cardiac Compass,
- Subjects requiring the implantation of an ICD for primary prevention according to the current AHA/ACC/ESC guidelines,
- Subject able to comply with the Clinical InvestigationPlan,
- Subject is expected to remain available for follow-up visits,
- Subject has signed the informed consent form within 10 days of implant,
- The system implanted for this study is the first ICD implant for patient.
Exclusion Criteria
- Women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
- Subject is enrolled in a concurrent study that may confound the results of this study,
- Subject has a life expectancy less than two years,
- Subject is post heart transplant or awaiting heart transplantation,
- Subject is anticipated to demonstrate poor compliance,
- Subjects with syndromes known to be associated with ion channel pathologies such as:
- Long- or short-QT Syndrome
- Brugada Syndrome
- Catecholaminergic Polymorphic Ventricular Tachycardia (CPTV ).
Data sourced from ClinicalTrials.gov (NCT00478933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.