DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

Medtronic

Status: Completed

Conditions: Atrial Fibrillation; Tachycardia; Ventricular Fibrillation; Death, Sudden, Cardiac; Sick Sinus Syndrome

Treatments: Procedure: Blood sampling; Device: Defibrillator, Dual Chamber ; Implantable

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478933

DISCOVERY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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1,223 participants in 1 patient group

ICD Therapy, blood sampling

Experimental group

Description:

Blood sampling Defibrillator, Dual Chamber ; Implantable

Treatment:

Device: Defibrillator, Dual Chamber ; Implantable

Procedure: Blood sampling