Study Population and protocol
Eligible subjects were consecutive male or females >18 years of age suffering from symptomatic drug resistant atrial fibrillation (AF) requiring catheter ablation. No other inclusion criteria were necessary. Exclusion criteria was the refusal of the post-interventional esophago-gastro-duodenoscopy (EGD). If subjects fulfilled all inclusion criteria and none of the exclusion criteria, they were randomized either to the fixed HPSD protocol or to the standard CLOSE-protocol.
After randomization of 40 patients further 80 patients were treated with the fixed HPSD protocol to increase the validity of the primary safety endpoint in the fixed HPSD group.
The clinical data, intraprocedural data and complications were analyzed of all study subjects. Three experienced operators performed all ablation procedures.