The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with stroke, reductions in quality of life and overall survival. Previous studies have shown that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation. However, the pulmonary vein isolation for radiofrequency catheter ablation in previous studies was done around each pulmonary-vein antrum, and it's not wide area circumferential ablation. Moreover, the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing was not performed in most of previous studies. We hypothesize that wide area circumferential ablation with contact force catheter and combined catheter ablation the potential atrial triggers and/or other atrial arrhythmias induced by aggressive induction is more effective than cryoballoon ablation in patients with paroxysmal atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Wide area circumferential ablation with contact force catheter will be performed in Patients allocated in this group,the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing will be performed. If frequent atrial premature beats are found beyond pulmonary vein, activation mapping will be performed for eliminating the triggers. If atrial tachycardias(ATs)are induced, activation mapping the ATs and ablation will be performed. Electrical isolation of pulmonary veins and elimination the triggers and ATs induced by isoproterenol or programmed stimulation and burst pacing are the endpoints of ablation
In the cryoballoon procedures, pulmonary vein isolation (PVI) was achieved using fluoroscopic guidance to position the cryoballoon catheter. Once PV-to-balloon occlusion was confirmed by retrograde radiopaque contrast agent retention, circumferential ablation was performed by freezing with a single-shot delivery of coolant to the balloon.
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Time to first documented recurrence of atrial arrhythmias
a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months
time to the first occurrence of each of the components of the primary outcome
a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months
all-cause death
all-cause death
Time frame: 12 months
Arrhythmia-related death
Arrhythmia-related death
Time frame: 12 months
total procedural duration
time of total procedural
Time frame: 12 months
total time of fluoroscopy
total time of fluoroscopy
Time frame: 12 months
time to recurrent atrial fibrillation (AF)
a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months
time to first cardiovascular hospitalization
a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months
number of cardiovascular hospitalizations (over-night stays)
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a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months
quality of life changes at 12 months compared to baseline
with the evaluation of the MOS item short from health survey(SF-36)
Time frame: 12 months
time to first symptomatic AF recurrence
a blanking period of three months will be maintained after the initial procedure
Time frame: 12 months