This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
For those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter.
In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter.
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts \> 30 seconds.
Time frame: at least 12 months follow up
Incidence of Peri-procedural Complications
Incidence of Peri-procedural Complications:stroke, cardiac perforation, PV stenosis, esophageal injury and death
Time frame: 1 week after patient enrollment
Total procedure time
time that the patient spend in the procedure room
Time frame: 1 week after patient enrollment
Total fluoroscopic time
the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification
Time frame: 1 week after patient enrollment
Total RF delivery time
The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure.
Time frame: 1 week after patient enrollment
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