Fehmi Keçe

Chapter 6 128 6.2 Methods 6.2.1 Study Population Patients eligible for a first cryoballoon ablation of paroxysmal AF were prospectively included between May 2014 and October 2016 and 1:1:1 randomized to an additional ablation of 90, 120 or 150 seconds (s) after time-to-isolation (Figure 1). Eligibility was determined with a pre-procedural CT-scan (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan) and defined as no PV diameter >26mm. Patients with previous catheter or surgical AF ablation or persistent AF were excluded. Study patients gave written informed consent for participation in the study and were blinded to group allocation. Data were collected using the departmental Cardiology Information System (EPD-Vision). The study was approved by the institutional ethical review board and registered at the Dutch national trial register (NL47833.058.14). Figure 1. Study protocol. Seventy-five patients were enrolled and 1:1:1 randomized into 3 groups of respectively 90, 120 and 150 additional ablation time after reaching isolation of the pulmonary vein. Additional ablations were applied in case of reconnection/dormant conduction. Ablations were aborted if no isolation occurred within 90s, in case of reduced phrenic nerve capture or endoluminal esophageal temperature below 18 °C.