Study Design
The current study was a single-centre prospective trial performed in
compliance with the guidelines for good clinical practice and the
Declaration of Helsinki. The study was approved by the institutional
ethical review board. All data were collected, managed and analysed at
the Klinikum Pirna (ethics votum University of Dresden: EK 28409202).
All eligible consecutive symptomatic AF patients referred for first time
ablation of AF were included between April and November of 2020. An
informed consent into the procedure was given by all patients.
The primary efficiency endpoints of this study were the
differences of total procedural time, the total RF application-time and
the time to PV isolation in the AI guided fixed HPSD protocol compared
to the standard CLOSE-protocol.
The secondary efficiency endpoints were the number of required RF
lesions, RF time per lesion, number of patients with first pass PV
isolation and the AF recurrence rate within the first 12 weeks after the
ablation procedure.
The primary safety endpoint was the number and
characteristics of thermal oesophageal lesions using the fixed HPSD
protocol compared to the standard CLOSE-protocol.
The secondary safety endpoint was the occurrence of procedural
related complications other then thermal oesophageal lesions using the
fixed HPSD protocol compared to the standard CLOSE-protocol.