Ventricular TachycardiaDATASNCT00157820

DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

A study testing Single Chamber Implantable Cardioverter Defibrillator and Dual Chamber implantable cardioverter defibrilator in people with Ventricular Tachycardia 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

The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non selected population with conventional indication of ICD implantation. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
What is being tested?: Single Chamber Implantable Cardioverter Defibrillator and Dual Chamber implantable cardioverter defibrilator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 354 participants
Where: No sites listed yet
Study dates: Nov 2000to Oct 2005
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).

Who cannot join

Permanent atrial fibrillation
Patients without structural heart disease
Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block ).
Patient with previous system implanted (ICD or pacemaker).
Patients with biventricular stimulation or re-synchronization.
Patient has a mechanical right heart valve.

Show all 10Show fewer

Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation.
Patient is unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent.
Patient is or will be inaccessible for follow-up at the study center.
Patients who are enrolled or planning to enroll in other clinical trials during the clinical study.

About this study

Read the detailed description

Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive rationale solution, although controversy remains if the costs and complexity of the implants offer a real clinical advantage.

The DATAS is a, prospective, multicentre, randomized, open labelled study, with three arms (two of them cross-over and the third parallels the other two)

The primary objective of this trial is to determine whether use of Dual Chamber ICD (DDED-DDDR NASPE/BPEG Defibrillator/Pacemaker Codes) results in a significant decrease in the number of primary end points.

The primary end point is a composite comprising four so-denominated "Clinically Significant Adverse Events (CSAE)":

all-cause mortality
invasive intervention, hospitalization (>24 h) or prolongation of hospitalization due to cardiovascular cause
inappropriate shocks (two or more episodes with inappropriate shocks)
sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention.

Secondary objectives are:

Number of each of the components of the CSAE.
Arrhythmia related: atrial tachyarrhythmia (AT), frequency and burden, ventricular tachyarrhythmia frequency and burden number of appropriate shocks, number of inappropriate shocks, need for reprogramming, need for medication/Radiofrequency Ablation (RFA) for arrhythmia control, pacemaker syndrome and development of dual chamber pacing indication.
Cardiovascular related: New York Health Association (NYHA) functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).
Quality of life: evaluated by the SF-36, Minnesota living test, with heart failure and Symptom Checklist instruments.

Conditions: Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
Being tested: Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
Keywords: Defibrillators, Implantable, Atrial Fibrillation, Ventricular Tachyarrhythmias, Clinical Trial
Medical subject headings: Tachycardia, Ventricular, Ventricular Fibrillation, Atrial Fibrillation

What participants receive

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

Single Chamber Implantable Cardioverter DefibrillatorDevice
Also called Medtronic GEM, Medtronic Marquis family of SC ICD
Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD
Dual Chamber implantable cardioverter defibrilatorDevice
Also called Medtronic Jewel AF, Medtronic GemIII AT, DC ICD
Dual chamber ICD implantation: Jewel AF \& GemIII AT as DC ICDs (DC true and SC sim arms)

Study groups in NCT00157820
Study group	Role	What they receive
SC true	Active comparator	Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber. Receives: Device: Single Chamber Implantable Cardioverter Defibrillator
SC sim	Experimental	Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'') Receives: Device: Dual Chamber implantable cardioverter defibrilator
DC true	Experimental	Dual chamber ICD initially programmed as a DDED (''DC true arm''). Receives: Device: Dual Chamber implantable cardioverter defibrilator

What is being measured

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

CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
Measured: 17 months

Secondary outcomes (1)

Number of Each of the Components of the CSAE
The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.
Number of each of the components of CSAE, counts the number of events for each pre-determined level.
Measured: 17 months

Timeline

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

Nov 2000Oct 2005

First posted12 Sep 2005 (estimated)
Study startNov 2000
Primary completionMay 2005
Study completionOct 2005

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 (4)Papers the sponsor has linked to this study.
Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00157820
Sponsor's protocol ID: SP-DATAS
Acronym: DATAS
Status last verified: Apr 2024
First submitted: 8 Sep 2005
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Quesada A, Almendral J, Arribas F, Ricci R, Wolpert C, Adragao P, Cobo E, Navarro X; DATAS Investigators. The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator. Europace. 2004 Mar;6(2):142-50. doi: 10.1016/j.eupc.2003.11.011.
PubMed 15018874
Almendral J, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A; DATAS Steering Committee; DATAS Writing Committee; DATAS Investigators. Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial. Europace. 2008 May;10(5):528-35. doi: 10.1093/europace/eun072. Epub 2008 Apr 7.
PubMed 18390985
Ricci RP, Quesada A, Almendral J, Arribas F, Wolpert C, Adragao P, Zoni-Berisso M, Navarro X, DeSanto T, Grammatico A, Santini M; DATAS study Investigators. Dual-chamber implantable cardioverter defibrillators reduce clinical adverse events related to atrial fibrillation when compared with single-chamber defibrillators: a subanalysis of the DATAS trial. Europace. 2009 May;11(5):587-93. doi: 10.1093/europace/eup072.
PubMed 19401341
Hadid C, Almendral J, Ortiz M, Schwab JO, Janko S, Mischke K, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A. Incidence, determinants, and prognostic implications of true pleomorphism of ventricular tachycardia in patients with implantable cardioverter-defribillators: a substudy of the DATAS Trial. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):33-42. doi: 10.1161/CIRCEP.110.957068. Epub 2010 Nov 13.
PubMed 21076160

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

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular

All Ventricular Tachycardia 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: DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
ClinicalTrials.gov ID: NCT00157820
Acronym / sponsor ID: DATAS / SP-DATAS
Conditions: Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
Keywords: Defibrillators, Implantable, Atrial Fibrillation, Ventricular Tachyarrhythmias, Clinical Trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 354 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Nov 2000
Primary completion: May 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

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

Detailed description

The DATAS is a, prospective, multicentre, randomized, open labelled study, with three arms (two of them cross-over and the third parallels the other two)

The primary end point is a composite comprising four so-denominated "Clinically Significant Adverse Events (CSAE)":

all-cause mortality
invasive intervention, hospitalization (>24 h) or prolongation of hospitalization due to cardiovascular cause
inappropriate shocks (two or more episodes with inappropriate shocks)
sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention.

Secondary objectives are:

Number of each of the components of the CSAE.
Arrhythmia related: atrial tachyarrhythmia (AT), frequency and burden, ventricular tachyarrhythmia frequency and burden number of appropriate shocks, number of inappropriate shocks, need for reprogramming, need for medication/Radiofrequency Ablation (RFA) for arrhythmia control, pacemaker syndrome and development of dual chamber pacing indication.
Cardiovascular related: New York Health Association (NYHA) functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).
Quality of life: evaluated by the SF-36, Minnesota living test, with heart failure and Symptom Checklist instruments.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SC true	Active comparator	Device: Single Chamber Implantable Cardioverter DefibrillatorSingle chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.
SC sim	Experimental	Device: Dual Chamber implantable cardioverter defibrilatorDual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'')
DC true	Experimental	Device: Dual Chamber implantable cardioverter defibrilatorDual chamber ICD initially programmed as a DDED (''DC true arm'').

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).

Key exclusion criteria (10 listed)

Permanent atrial fibrillation
Patients without structural heart disease
Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block ).
Patient with previous system implanted (ICD or pacemaker).
Patients with biventricular stimulation or re-synchronization.

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
Single Chamber Implantable Cardioverter DefibrillatorAlso: Medtronic GEM, Medtronic Marquis family of SC ICDSingle chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD	Device	SC true
Dual Chamber implantable cardioverter defibrilatorAlso: Medtronic Jewel AF, Medtronic GemIII AT, DC ICDDual chamber ICD implantation: Jewel AF \& GemIII AT as DC ICDs (DC true and SC sim arms)	Device	DC true, SC sim

Primary outcome

CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
Time frame: 17 months
Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.

1 secondary outcome

Number of Each of the Components of the CSAE
Time frame: 17 months

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SC True	118	111
SC Simulated Then DC True	116	111
DC True Then SC Sim	120	112

Primary outcome: CSAE-score Rate(Clinical Significant Adverse Events Score Rate)

Time frame: 17 months. Number. Unit: score/month

Measure	SC True n = 111	SC Simulated n = 223	DC True n = 223
Value	0.112	0.128	0.075

SC True vs DC True: Odds Ratio (OR): 0.31 (95% CI 0.14 to 0.67), p = 0.0028, Wilcoxon (Mann-Whitney)

Population analysed: ITT

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of the enrollment+follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SC True	50 of 111 (45%)	13 of 111 (11.7%)	Not reported
SC Simulated	49 of 223 (22%)	8 of 223 (3.6%)	Not reported
DC True	44 of 223 (19.7%)	3 of 223 (1.3%)	Not reported

Limitations and caveats (from the sponsor): The follow-up might have been too short to reveal differences in heart failure-related hospitalizations and related mortality. Premature crossovers are a limitation of RCT. However, our scoring system severely penalized this cross-overs.

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.
Background: PubMed 15018874Quesada A, Almendral J, Arribas F, Ricci R, Wolpert C, Adragao P, Cobo E, Navarro X; DATAS Investigators. The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator. Europace. 2004 Mar;6(2):142-50. doi: 10.1016/j.eupc.2003.11.011.
Results publication: PubMed 18390985Almendral J, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A; DATAS Steering Committee; DATAS Writing Committee; DATAS Investigators. Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial. Europace. 2008 May;10(5):528-35. doi: 10.1093/europace/eun072. Epub 2008 Apr 7.
Results publication: PubMed 19401341Ricci RP, Quesada A, Almendral J, Arribas F, Wolpert C, Adragao P, Zoni-Berisso M, Navarro X, DeSanto T, Grammatico A, Santini M; DATAS study Investigators. Dual-chamber implantable cardioverter defibrillators reduce clinical adverse events related to atrial fibrillation when compared with single-chamber defibrillators: a subanalysis of the DATAS trial. Europace. 2009 May;11(5):587-93. doi: 10.1093/europace/eup072.
Results publication: PubMed 21076160Hadid C, Almendral J, Ortiz M, Schwab JO, Janko S, Mischke K, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E, Navarro X, Quesada A. Incidence, determinants, and prognostic implications of true pleomorphism of ventricular tachycardia in patients with implantable cardioverter-defribillators: a substudy of the DATAS Trial. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):33-42. doi: 10.1161/CIRCEP.110.957068. Epub 2010 Nov 13.
Individual participant dataSharing planned: No

Related trials for Ventricular Tachycardia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular

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.

Aurelio Quesada, MD principal investigator

Hospital General Universitario, Valencia, Spain

Jesus Almendral, MD principal investigator

Hospital General Universitario Gregorio Marañon, Madrid, Spain

Fernando Arribas, MD principal investigator

Hospital Universitario 12 de Octubre, Madrid, Spain

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 10 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 21 Aug 2012). 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?

CSAE-score Rate(Clinical Significant Adverse Events Score Rate) (time frame: 17 months). 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 NCT00157820, which also lists 4 linked publications.

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.