This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea
Recurrence rate of AF/AFL/AT in both groups
recurrence of AF/AFL/AT evaluated using device interrogation
Time frame: 1 year after randomization
Recurrence rate of AF/AFL/AT in both groups
recurrence of AF/AFL/AT evaluated using device interrogation
Time frame: 6-month follow up to 5 years
Left ventricular ejection fraction
cardiac function evaluated using echocardiography
Time frame: 1 year after randomization
Left atrial diameter
cardiac function evaluated using echocardiography
Time frame: 1 year after randomization
Stroke
ischemic and hemorrhagic stroke
Time frame: at least 1 year after randomization
Stroke
ischemic and hemorrhagic stroke
Time frame: 6-month follow up to 5 years
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