Clinical trial NCT00157820: DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Official title: DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Defibrillators, Implantable
Keywords: Defibrillators, Implantable
Atrial Fibrillation
Ventricular Tachyarrhythmias
Clinical Trial
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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)":

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

Secondary objectives are:

1. Number of each of the components of the CSAE.
2. 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.
3. Cardiovascular related: New York Health Association (NYHA) functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).
4. Quality of life: evaluated by the SF-36, Minnesota living test, with heart failure and Symptom Checklist instruments.

Eligibility criteria: 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.

Primary outcomes:
measure: CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
timeFrame: 17 months
Secondary outcomes:
measure: Number of Each of the Components of the CSAE
timeFrame: 17 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Universitario, Valencia, Spain
name: Aurelio Quesada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Marañon, Madrid, Spain
name: Jesus Almendral, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain
name: Fernando Arribas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Filippo Neri Hospital, Rome, Italy
name: Massimo Santini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Mannheim, Mannheim, Germany
name: Christian Wolpert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Cruz Hospital, Carnaxide, Portugal
name: Pedro Adragao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.