N/A
N=354
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Ventricular Tachycardia · Ventricular Fibrillation · Defibrillators, Implantable
Bottom Line
View on ClinicalTrials.gov: NCT00157820 ↗Enrolled (actual)
354
Serious AEs
25.7%
Results posted
Aug 2012
Primary outcome: Primary: CSAE-score Rate(Clinical Significant Adverse Events Score Rate) — 0.112; 0.128; 0.075 score/month — p=0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single Chamber Implantable Cardioverter Defibrillator (Device); Dual Chamber implantable cardioverter defibrilator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- May 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSAE-score Rate(Clinical Significant Adverse Events Score Rate) |
0.112; 0.128; 0.075 | 0.0028 sig |
| SECONDARY Number of Each of the Components of the CSAE |
10; 11; 4; 11; 12; 10 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00157820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.