DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

Conditions
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Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable

Intervention / Treatment
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* Device: Single Chamber Implantable Cardioverter Defibrillator
* Device: Dual Chamber implantable cardioverter defibrilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA). Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SC true<br>Single chamber Implantable Cardioverter Defibrillator programmed as a Single Chamber. | Device: Single Chamber Implantable Cardioverter Defibrillator<br>* Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD<br>* Other names: Medtronic GEM, Medtronic Marquis family of SC ICD;|
| Experimental: SC sim<br>Dual chamber ICD initially programmed as single chamber (SC simulated) ICD (''SC sim arm'') | Device: Dual Chamber implantable cardioverter defibrilator<br>* Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)<br>* Other names: Medtronic Jewel AF, Medtronic GemIII AT, DC ICD;|
| Experimental: DC true<br>Dual chamber ICD initially programmed as a DDED (''DC true arm''). | Device: Dual Chamber implantable cardioverter defibrilator<br>* Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)<br>* Other names: Medtronic Jewel AF, Medtronic GemIII AT, DC ICD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 17 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Defibrillators, Implantable, Atrial Fibrillation, Ventricular Tachyarrhythmias, Clinical Trial