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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC true | Active Comparator | Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber. |
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| SC sim | Experimental | Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'') |
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| DC true | Experimental | Dual chamber ICD initially programmed as a DDED (''DC true arm''). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Chamber Implantable Cardioverter Defibrillator | Device | Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurelio Quesada, MD | Hospital General Universitario, Valencia, Spain | Principal Investigator |
| Jesus Almendral, MD | Hospital General Universitario Gregorio Marañon, Madrid, Spain | Principal Investigator |
| Fernando Arribas, MD | Hospital Universitario 12 de Octubre, Madrid, Spain | Principal Investigator |
| Massimo Santini, MD | San Filippo Neri Hospital, Rome, Italy | Principal Investigator |
| Christian Wolpert, MD | University Hospital Mannheim, Mannheim, Germany | Principal Investigator |
| Pedro Adragao, MD | Santa Cruz Hospital, Carnaxide, Portugal | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15018874 | Background | 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. | |
| 18390985 | Result |
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The Dual chamber true (DC true) and Single chamber simulated (SC sim) arms crossed over after 8 months. All other crossovers were considered 'premature crossovers' and had to be authorized by an independent Adverse Events Advisory Committee.
A 1-month wash out period was implemented after programmed crossover.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SC True | Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes) |
| FG001 | SC Simulated Then DC True | Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
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| Dual Chamber implantable cardioverter defibrilator | Device | Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms) |
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| 17 months |
| 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. |
| 19401341 | Result | 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. |
| 21076160 | Result | 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. |
| FG002 | DC True Then SC Sim | Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated |
| COMPLETED |
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| NOT COMPLETED |
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| 1st 8 Month |
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| 1 Month Wash Out Period |
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| 2nd 8 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | SC True | Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes) |
| BG001 | SC Simulated Then DC True | Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes. |
| BG002 | DC True Then SC Sim | Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| LVEF | Left Ventricle Ejection Fraction (percentage) | Mean | Standard Deviation | percentage |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT | Posted | Number | score/month | 17 months | CSAE | CSAE |
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| Secondary | 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. | Posted | Number | events | 17 months |
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Duration of the enrollment+follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SC True | Allocated to Single Chamber ICD (SC true arm) | 50 | 111 | 13 | 111 | ||
| EG001 | SC Simulated | Dual chamber ICD initially programmed as Single Chamber ICD (simulated | 49 | 223 | 8 | 223 | ||
| EG002 | DC True | Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") | 44 | 223 | 3 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
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| Invasive interventions | Cardiac disorders | Systematic Assessment |
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| Hospitalization or prolongued hospitalizations | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Innapropiate shocks | Cardiac disorders | Systematic Assessment |
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| Sustain Symptomatic AT | Cardiac disorders | Systematic Assessment | sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.A.Quesada | Hospital General Universitario de Valencia, Spain | aquesadad@secardiologia.es |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Premature cross-over |
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| Premature cross-over |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Germany |
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| Italy |
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| Israel |
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| United Kingdom |
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| Portugal |
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| Superiority or Other (legacy) |
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