About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
Age: 18-80 years
Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
Disqualifiers
Persistent or permanent AF
Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
Thyroid gland dysfunction
Pregnancy
Trial design
Parallel
Treatments tested in this trial
midazolam with fentanyl
DrugRadio-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.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence rate of AF/AFL/AT in both groups
recurrence of AF/AFL/AT evaluated using device interrogation
Recurrence rate of AF/AFL/AT in both groups
recurrence of AF/AFL/AT evaluated using device interrogation
Secondary outcomes
Left ventricular ejection fraction
cardiac function evaluated using echocardiography
Left atrial diameter
cardiac function evaluated using echocardiography
Stroke
ischemic and hemorrhagic stroke
Stroke
ischemic and hemorrhagic stroke
Sponsors and contacts
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