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titlelines DAPPAF Clinical Trial

Title of Trial
Dual Site Atrial Pacing to Prevent Atrial Fibrillation (DAPPAF) Trial

Date and Citation of Primary Publication(s) or References
Saksena S, Prakash A, Ziegler P, et al. Improved suppression of recurrent atrial fibrillation with dual-site right atrial pacing and antiarrhythmic drug therapy. J Am Coll Card 2002; 40: 1140-50.

Purpose of the Trial
Evaluate the effects of multisite pacing in patients with atrial fibrillation

Study Categories
Pacemakers

Patient Population

Inclusion Criteria
Patients 21-80 years old with 2 or more symptomatic atrial fibrillation episodes in the previous 3 months with spontaneous or drug induced bradycardia requiring permanent pacing.

Exclusion Criteria
Implantable cardioverter defibrillators, contraindication to permanent pacing, or poor (< 18 months) prognosis due to noncardiovascular illness.

Study Design
Randomized crossover trial. Patients underwent pacing system implantation with one atrial lead in the high right atrium, one atrial lead at the coronary sinus os and a ventricular lead. Patients were randomized to dual right atrial pacing with overdrive suppression (80 bpm), high right atrial pacing with overdrive suppression, or support pacing (DDI or VDI pacing modes at 50 bpm) for six-month intervals.

Primary Endpoints
Time to first symptomatic atrial fibrillation episode, quality-of-life, and safety.

Secondary Endpoints
All atrial fibrillation episodes

Baseline Characteristics

Patient number: 118 patients

Mean Age: 66 ± 11 years

Gender: 38% female

Other characteristics: Indications for permanent pacing: Sinus bradycardia: 54%, sinus arrest: 15%, drug-induced bradycardia: 19%, asymptomatic sinus node dysfunction: 8%, other: 10%. Percentage of patients on antiarrhythmic medications: Class I drugs: 20%, Class III drugs: 41%, beta-blockers: 28%, calcium channel blockers: 13%, and digoxin: 25%.

Follow-up
Mean total study follow-up was 12.1± 6.9 months.

Results
No differences in adverse events among the three pacing modes were identified. Implant related problems occurred in 8.5% of patients. Time to first recurrent symptomatic atrial fibrillation was longer in patients with dual site atrial pacing (dual-site: 1.77 mo, RA with overdrive suppression: 0.62 mo,; p < 0.09, support pacing: 0.44 mo; p < 0.05. At the end of the six months freedom from symptomatic atrial fibrillation was not significantly different among the three pacing modes. However, in a subgroup of patients receiving Class I or III antiarrhythmic drugs, freedom from symptomatic atrial fibrillation was 72% in the dual RA pacing period, 65% for RA pacing with overdrive suppression, and 53% for support pacing (p < 0.01 for dual site vs. RA pacing with overdrive suppression or support pacing).

Table 1:

Endpoints Dual site pacing Single site RA
pacing with overdrive
suppression
Support pacing
Time to first recurrence of atrial fibrillation (mo) 1.77 0.62 0.44
Free of symptomatic AF
    3 mo
    6 mo
 
78%
69%
 
73%
68%
 
66%
61%
Free of symptomatic AF
(on class I or III drugs)
    3 mo
    6 mo
 
 
74%
72%
 
 
72%
65%
 
 
62%
53%


Sponsor:  Medtronic

Trial Status:  Completed

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