An interventional study of Single Chamber Implantable Cardioverter Defibrillator and Dual Chamber implantable cardioverter defibrilator in Ventricular Tachycardia, Ventricular Fibrillation and Defibrillators, Implantable, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Prevention
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.
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)":
Secondary objectives are:
431 studies on the registry are indexed under Tachycardia, Ventricular; 119 are open to participants now.
This study's enrollment of 354 is above the median of 64 across 260 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber.
Device: Single Chamber Implantable Cardioverter Defibrillator
Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'')
Device: Dual Chamber implantable cardioverter defibrilator
Dual chamber ICD initially programmed as a DDED (''DC true arm'').
Device: Dual Chamber implantable cardioverter defibrilator
Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD
Also known as: Medtronic GEM, Medtronic Marquis family of SC ICD
Dual chamber ICD implantation: Jewel AF \& GemIII AT as DC ICDs (DC true and SC sim arms)
Also known as: Medtronic Jewel AF, Medtronic GemIII AT, DC ICD
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.
Time frame: 17 months
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.
Time frame: 17 months
Patients were eligible if they met a standard Class I indication for a Single Chamber-Implantable Cardioverter Defibrillator (ICD) according to the 1998 ACC/AHA guidelines. Every patient eligible for ICD was screened at each study centre. Follow-up started immediately after randomization.
| Milestone | SC True | SC Simulated Then DC True | DC True Then SC Sim |
|---|---|---|---|
| Started | 118 | 116 | 120 |
| Completed | 111 | 111 | 112 |
| Not completed | 7 | 5 | 8 |
| Withdrew: Physician decision | 4 | 2 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 | 3 |
| Withdrew: Protocol violation | 2 | 1 | 2 |
| Milestone | SC True | SC Simulated Then DC True | DC True Then SC Sim |
|---|---|---|---|
| Started | 111 | 111 | 112 |
| Completed | 103 | 99 | 106 |
| Not completed | 8 | 12 | 6 |
| Withdrew: Death | 7 | 8 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 | 1 |
| Withdrew: Premature cross-over | 0 | 2 | 2 |
| Milestone | SC True | SC Simulated Then DC True | DC True Then SC Sim |
|---|---|---|---|
| Started | 103 | 101 | 108 |
| Completed | 103 | 101 | 108 |
| Not completed | 0 | 0 | 0 |
| Milestone | SC True | SC Simulated Then DC True | DC True Then SC Sim |
|---|---|---|---|
| Started | 103 | 101 | 108 |
| Completed | 98 | 88 | 94 |
| Not completed | 5 | 13 | 14 |
| Withdrew: Death | 3 | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 5 | 2 |
| Withdrew: Premature cross-over | 1 | 7 | 9 |
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.
| score/month | SC True | SC Simulated | DC True |
|---|---|---|---|
| CSAE-score Rate(Clinical Significant Adverse Events Score Rate) | 0.112 | 0.128 | 0.075 |
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.
| events | SC True | SC Simulated | DC True |
|---|---|---|---|
| Death | 10 | 11 | 4 |
| Invasive intervention CV | 11 | 12 | 10 |
| Hospitalizations (>24h) or prolongued CV | 42 | 51 | 47 |
| Inappropiate shocks (>2 episodes) | 13 | 7 | 3 |
| Long Duration AT | 6 | 3 | 1 |
Collected over Duration of the enrollment+follow up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SC True | — | 50/111 (45%) | 13/111 (11.7%) |
| SC Simulated | — | 49/223 (22%) | 8/223 (3.6%) |
| DC True | — | 44/223 (19.7%) | 3/223 (1.3%) |
| Event | SC True | SC Simulated | DC True |
|---|---|---|---|
| Hospitalization or prolongued hospitalizationsCardiac disorders | 33/111 | 32/223 | 36/223 |
| Invasive interventionsCardiac disorders | 11/111 | 12/223 | 9/223 |
| DeathGeneral disorders | 10/111 | 11/223 | 4/223 |
| Event | SC True | SC Simulated | DC True |
|---|---|---|---|
| Innapropiate shocksCardiac disorders | 10/111 | 7/223 | 2/223 |
| Sustain Symptomatic ATCardiac disorders | 5/111 | 4/223 | 1/223 |
| Age, Categorical(Participants) | SC True | SC Simulated Then DC True | DC True Then SC Sim | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 63 | 61 | 53 | 177 |
| >=65 years | 48 | 50 | 59 | 157 |
| Age, Continuous(years) | SC True | SC Simulated Then DC True | DC True Then SC Sim | Total |
|---|---|---|---|---|
| Mean | 63 ± 10 | 62 ± 11 | 66 ± 9 | 64 ± 10 |
| Sex: Female, Male(Participants) | SC True | SC Simulated Then DC True | DC True Then SC Sim | Total |
|---|---|---|---|---|
| Female | 11 | 21 | 20 | 52 |
| Male | 100 | 90 | 92 | 282 |
| Region of Enrollment(participants) | SC True | SC Simulated Then DC True | DC True Then SC Sim | Total |
|---|---|---|---|---|
| Spain | 43 | 44 | 44 | 131 |
| Germany | 29 | 29 | 31 | 89 |
| Italy | 21 | 21 | 19 | 61 |
| Israel | 9 | 8 | 9 | 26 |
| United Kingdom | 6 | 6 | 6 | 18 |
| Portugal | 3 | 3 | 3 | 9 |
| LVEF(percentage) | SC True | SC Simulated Then DC True | DC True Then SC Sim | Total |
|---|---|---|---|---|
| Mean | 35 ± 13 | 39 ± 14 | 34 ± 12 | 36 ± 13 |
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medtronic Cardiac Rhythm and Heart Failure