AF Ablation With High Power Short Duration RF

Condition(s) studied

Study summary

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF).

Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).

Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.

At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

Eligibility

Primary outcome measure(s)

• Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD. — 12 months after ablation
  to assess the efficacy of the procedure in terms of atrial arrhythmia recurrence-free rate (binary outcome), with a number of candidate predictors equal to 10

Trial sites (9)

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