Dual Site Atrial Pacing to Prevent Atrial Fibrillation - DAPPAF

May 14, 2002
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Date Presented:
01/01/1998
Date Published:
01/01/1998
Date Updated:
05/14/2002
Original Posted Date:
05/14/2002
References

Description:

This study compares three different modalities of pacing for the prevention of atrial fibrillation: Dual site atrial pacing, single site atrial pacing, and support pacing modalities (DDI at 50 bpm or VDI).

Hypothesis:

Pacing with a dual site atrial system will have a decreased incidence of recurrent atrial fibrillation and an improved quality of life as compared to single site atrial pacing and support pacing.

Study Design

Study Design:

Patients Enrolled: 120
Mean Follow Up: 18 Months
Mean Patient Age: 21-80

Patient Populations:

Patients with paroxysmal atrial fibrillation and at least 2 documented AF episodes in the three months prior to enrollment and a bradyarrhythmic indication for pacing.

Exclusions:

Patients with indications for pacing due to AV node block. Patients with prior ICD placement. Patients with a life expectancy <18 months.

Primary Endpoints:

1. Time to first recurrence of clinically significant symptomatic AF with ECG verification 2. Quality of life among the three treatment modes 3. Safety of the pacing system for this indication

Secondary Endpoints:

1. Time to first recurrence of all AF episodes as monitored by the pacemaker 2. The measurement of echocardiographic parameters including atrial and ventricular size as well as function. 3. Symptoms logged by the patients

Drug/Procedures Used:

Patients undergo implantation of a pacing system with a DDDR pulse generator with programmable polarity, rate response, and mode switching ability. An activation fixation lead for placement in the coronary sinus and a Y adaptor for connection of the two atrial leads to the generator are implated as well. Patients cross over every 6 months to the other 2 modes of pacing until all three modes have been used.

Concomitant Medications:

The patients may receive concurrent antiarrhythmic drug regimens but this regimen must remain constant throughout the protocol

Principal Findings:

Final results have not been reported

References:

1. Fitts SM, Hill MR, Mehra R, Friedman P, Hammill S, Kay GN, Prakash A, Webb C, Saksena S. Design and implementation of the Dual Site Atrial Pacing to Prevent Atrial Fibrillation (DAPPAF) clinical trial. DAPPAF Phase 1 Investigators. J Interv Card Electrophysiol 1998 Jun;2(2):139-44.

Keywords: Heart Atria, Coronary Sinus, Quality of Life, Furylfuramide, Dichlorodiphenyldichloroethane, Heart Conduction System, Bradycardia


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