Death, Sudden, CardiacDISCOVERYNCT00478933

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

A study testing Defibrillator, Dual Chamber ; Implantable and Blood sampling in people with Death, Sudden, Cardiac and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia
What is being tested?: Defibrillator, Dual Chamber ; Implantable and Blood sampling
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,223 participants
Where: No sites listed yet
Study dates: Feb 2007to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:

Show all 9Show fewer

Long- or short-QT Syndrome
Brugada Syndrome
Catecholaminergic Polymorphic Ventricular Tachycardia (CPTV ).

About this study

Official title: Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients.

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.

Read the 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.

Conditions: Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
Being tested: Defibrillator, Dual Chamber ; Implantable, Blood sampling
Keywords: Arrhythmia, Ventricular, Atrial, Tachycardia, Fibrillation, Flutter, GNB3, GNAS, GNAQ
Medical subject headings: Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Defibrillator, Dual Chamber ; ImplantableDevice
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 samplingProcedure or surgery
Blood sampling

Study groups in NCT00478933
Study group	Role	What they receive
ICD Therapy, blood sampling	Experimental	Blood sampling Defibrillator, Dual Chamber ; Implantable Receives: Device: Defibrillator, Dual Chamber ; Implantable; Procedure: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype
The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype
The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype
The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype
The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype
The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype
The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years
Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype
The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Measured: 2 years

Secondary outcomes (2)

Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics
Measured: 2 years
All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Dec 2012

First posted25 May 2007 (estimated)
Study startFeb 2007
Primary completionJul 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00478933
Sponsor's protocol ID: DISCOVERY
Acronym: DISCOVERY
Status last verified: Jul 2017
First submitted: 23 May 2007
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: study is closed several years ago; this is not applicable for this study

Publications

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.
PubMed 27895044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Death, Sudden, Cardiac trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Tachy-arrhythmia in ICD Patients.
ClinicalTrials.gov ID: NCT00478933
Acronym / sponsor ID: DISCOVERY / DISCOVERY
Conditions: Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
Keywords: Arrhythmia, Ventricular, Atrial, Tachycardia, Fibrillation, Flutter, GNB3, GNAS
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,223 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jul 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 25 May 2007 (estimated)
Results: Posted 22 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 1

Arm	Type	Receives
ICD Therapy, blood sampling	Experimental	Device: Defibrillator, Dual Chamber ; Implantable, Procedure: Blood samplingBlood sampling Defibrillator, Dual Chamber ; Implantable

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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,

Key exclusion criteria (9 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Defibrillator, Dual Chamber ; ImplantablePatient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.	Device	ICD Therapy, blood sampling
Blood samplingBlood sampling	Procedure or surgery	ICD Therapy, blood sampling

Primary outcome

Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype
Time frame: 2 years
The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype
Time frame: 2 years
The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype
Time frame: 2 years
The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype
Time frame: 2 years
The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype
Time frame: 2 years
The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype
Time frame: 2 years
The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.
Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype
Time frame: 2 years
The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

2 secondary outcomes

Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics
Time frame: 2 years
All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter
Time frame: 2 years

Results and safety

Results posted to the registry on 22 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD Therapy, Blood Sampling	1,223	1,145

Primary outcome: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype

Time frame: 2 years. Number. Unit: participants with VT < 400 msec

Measure	c.393C>T CC Genotype n = 285	c.393C>T CT Genotype n = 555	c.393C>T TT Genotype n = 305
Value	63	136	98

Primary outcome: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype

Time frame: 2 years. Number. Unit: participants with VT < 400 msec

Measure	c.2273C>T CC Genotype n = 456	c.2273C>T CT Genotype n = 533	c.393C>T TT Genotype n = 156
Value	103	136	59

Primary outcome: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype

Time frame: 2 years. Number. Unit: participants with VT < 400 msec

Measure	c.2291C>T CC Genotype n = 527	c.2291C>T CT Genotype n = 508	c.2291C>T TT Genotype n = 110
Value	145	123	29

Primary outcome: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype

Time frame: 2 years. Number. Unit: participants with VT < 400 msec

Measure	GNAQ c.-909/-908GC>TT GC/GC Genotype n = 342	GNAQ c.-909/-908GC>TT GC/TT Genotype n = 546	GNAQ c.-909/-908GC>TT TT/TT Genotype n = 257
Value	85	143	69

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD Therapy, Blood Sampling	265 of 1,145 (23.1%)	45 of 1,145 (3.9%)	Not reported

Limitations and caveats (from the sponsor): The following limitations can be noted: • Patient follow-up was prematurely terminated after at least 12-month follow-up data on all enrolled patients but before the planned 24-month follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27895044Wieneke 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.
Individual participant dataSharing planned: No. study is closed several years ago; this is not applicable for this study

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Domenico Corrado, MD principal investigator

University of Padova, Italy

Heiner Wieneke, MD principal investigator

Universitätsklinikum Essen, Germany

Questions about this trial

What is this clinical trial studying?

A study testing Defibrillator, Dual Chamber ; Implantable and Blood sampling in people with Death, Sudden, Cardiac and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00478933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.