N/A N=1,223 Triple-blind Diagnostic

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

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

Bottom Line

View on ClinicalTrials.gov: NCT00478933 ↗

Enrolled (actual)

1,223

Serious AEs

23.1%

Results posted

Nov 2017

Primary outcome: Primary: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype — 63; 136; 98 participants with VT < 400 msec

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Defibrillator, Dual Chamber ; Implantable (Device); Blood sampling (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Jul 2012

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	—	—

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.

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 ).

View full record on ClinicalTrials.gov →

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.