DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (NCT00157820) | Clinical Trial Compass
CompletedNot Applicable
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
354 participantsStarted 2000-11
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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.