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Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
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.
Official title: Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2025-04-09
Completion Date
2026-10-09
Last Updated
2025-04-16
Healthy Volunteers
No
Conditions
Interventions
Pulmonary vein isolation plus transition zone modification
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.
Pulmonary vein isolation alone
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.