DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients. - Full Text View

Sponsor:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00478933

Purpose

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.

Condition	Intervention	Phase
Death, Sudden, Cardiac Ventricular Fibrillation Tachycardia Atrial Fibrillation Sick Sinus Syndrome	Device: Defibrillator, Dual Chamber ; Implantable Procedure: Blood sampling	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic
Official Title:	Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-Arrhythmia in ICD Patients.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome Help Me Understand Genetics

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

positive predictive value of single nucleotide polymorphisms (SNPs) in the genes GNB3, GNAS and GNAQ as predictors of ventricular arrhythmia <400 msec. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hospitalization, medical interventions, medication, surgery, additional diagnostics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
All Cause Mortality, Cardiac death and atrial fibrillation/flutter [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1300
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

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.
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.
Evaluate the usage of ICD-system diagnostics (battery status, impedance, pacing threshold, sensing) resulting in medical consequences*.
Evaluate the usage of ICD-based patient diagnostics (arrhythmia, IEGM, heart frequency, %pacing, Cardiac Compass) resulting in medical consequences*.
Evaluate the frequency of programming changes involving AF-prevention and AF-therapy algorithms.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 ).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478933

Contacts

Contact: Marc D Messier, Ph.D.		marc.messier@medtronic.com
Contact: Antoine Cuijpers, M.Sc.		antoine.cuijpers@medtronic.com

Locations

Germany
Universitätsklinikum Essen	Recruiting
Essen, Germany, 45122
Contact: Heiner Wieneke, MD heiner.wieneke@gmx.de
Principal Investigator: Heiner Wieneke, MD

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Principal Investigator:	Domenico Corrado, MD	University of Padova, Italy
Principal Investigator:	Heiner Wieneke, MD	Universitätsklinikum Essen, Germany

More Information

No publications provided

Responsible Party:	Marc Messier , Outcomes Study Manager, Clin Outcomes Research and Biometry, MEDTRONIC Bakken Research Center B.V.
ClinicalTrials.gov Identifier:	NCT00478933 History of Changes
Other Study ID Numbers:	DISCOVERY
Study First Received:	May 23, 2007
Last Updated:	January 13, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Medtronic Bakken Research Center:

Arrhythmia
Ventricular
Atrial
Tachycardia
Fibrillation

Flutter
GNB3
GNAS
GNAQ

Additional relevant MeSH terms:

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

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death
Arrhythmia, Sinus
Heart Block
Heart Arrest

ClinicalTrials.gov processed this record on February 09, 2012