DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

NCT ID: NCT00478933

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2012-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

ICD Therapy, blood sampling

Blood sampling Defibrillator, Dual Chamber ; Implantable

Group Type: EXPERIMENTAL

Defibrillator, Dual Chamber ; Implantable

Intervention Type: DEVICE

Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.

Blood sampling

Intervention Type: PROCEDURE

Blood sampling

Interventions

Defibrillator, Dual Chamber ; Implantable

Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.

Intervention Type: DEVICE

Blood sampling

Blood sampling

Intervention Type: PROCEDURE

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 ).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Domenico Corrado, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova, Italy

Heiner Wieneke, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Essen, Germany

References

Wieneke H, Svendsen JH, Lande J, Spencker S, Martinez JG, Strohmer B, Toivonen L, Le Marec H, Garcia-Fernandez FJ, Corrado D, Huertas-Vazquez A, Uy-Evanado A, Rusinaru C, Reinier K, Foldesi C, Hulak W, Chugh SS, Siffert W. Polymorphisms in the GNAS Gene as Predictors of Ventricular Tachyarrhythmias and Sudden Cardiac Death: Results From the DISCOVERY Trial and Oregon Sudden Unexpected Death Study. J Am Heart Assoc. 2016 Nov 28;5(12):e003905. doi: 10.1161/JAHA.116.003905.

Reference Type: DERIVED

PMID: 27895044 (View on PubMed)

Other Identifiers

DISCOVERY

Identifier Type: -

Identifier Source: org_study_id