Design and implementation of the Dual Site Atrial Pacing to Prevent AtrialFibrillation (DAPPAF) clinical trial

The Dual Site Atrial Pacing to Prevent Atrial Fibrillation (DAPPAF) study c ompares dual site, single site and support pacing modalities in the prevent ion of atrial fibrillation (AF) in patients with a history of paroxysmal AF (PAF) and a bradyarrhythmic indication for pacing. The trial is a randomiz ed crossover comparison of dual site atrial pacing, single site atrial paci ng, and a support pacing control period (DDI at 50 ppm or VDI) done in six month intervals. Patient inclusion requires at least 2 documented AF episod es in the three months prior to enrollment. The patients can be on concurre nt antiarrhythmic drug regimens but this regimen must remain constant throu ghout the protocol. Patients with AV nodal ablation are excluded from this study. The primary endpoints of the study compare the time to first recurre nce of clinically significant symptomatic AF with ECG verification, and qua lity of life among the three treatment modes. Secondary endpoints include t ime to first recurrence of all AF episodes as monitored by the pacemaker, t he measurement of echocardiographic parameters, and symptoms logged by the patients. This trial was designed after pilot studies showed dual site paci ng to be safe, feasible and preliminary results suggested increased mainten ance of sinus rhythm with atrial pacing.