Atrial Fibrillation Clinical Trial
Official title:
Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death
While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for
sudden death prevention in high risk individuals, reduction of device associated morbidity
remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately
detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks
in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown
modest benefits of atrial pacing in preventing atrial fibrillation, however right
ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial
prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV
pacing are now made available in our current devices. The choice of dual chamber versus
single chamber ICD for primary prevention warrants re-assessment of atrial prevention and
termination therapies, without the potentially adverse effects of RV pacing.
This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50
to dual chamber ICDs. Patients will be followed for one year.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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