CIPA stands for: Complex fractionated atrial electrocardiograms (CFAEs) guided ablation versus pulmonary vein isolation guided ablation in persistent atrial fibrillation, a multicentre randomized trial
Introduction
The purpose of this study is to compare the efficacy and safety of complex fractionated atrial electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation (PVI) based ablation in patients with persistent atrial fibrillation (AF).
This study is an international (including non EU-countries), multicenter, prospective, randomized, unblinded, clinical study.
Patients will be randomized based on a 2:1 ratio into one of two study arms:
- CFAE guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation, according to methods by Nademanee. PVI will be checked before and after ablation using a mapping catheter
- PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals
The trial is designed to enrol 120 patients. The first patient was included in the Isala hospital in the Netherlands in May 2016.
Primary endpoint
The study’s primary endpoint is freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) without the use of class I or III AADs through 18 months follow-up, post blanking period after ablation on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring.
Potential benefit
The direct benefit for patients undergoing ablation is the potential elimination of AF episodes. It is furthermore expected that quality of life will improve and less frequent hospitalization will be needed. Whether further morbidity as cerebral vascular events are prevented is subject to discussion. The information gained from the conduct of this study may benefit patients with AF by improving future treatment modalities.
Clinical investigators
The principal investigator of the study is J.J.J. Smit, MD PhD of the Isala hospital, Zwolle.