Permanent Pacemaker Implantation
Conditions
Keywords
ablation, atrial fibrillation, stroke
Brief summary
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.
Interventions
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Estimated percentage of ventricular pacing \>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate) * Patients who are willing to sign the informed consent. * Patients who are willing to receive the implantation and post-operative follow-up.
Exclusion criteria
* 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 * Malignant tumor * Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) * Life expectancy \< 12 months * Patients unable or unwilling to cooperate in the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of AF/AFL/AT in both groups | 1 year after randomization | recurrence of AF/AFL/AT evaluated using device interrogation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | 1 year after randomization | cardiac function evaluated using echocardiography |
| Left atrial diameter | 1 year after randomization | cardiac function evaluated using echocardiography |
| Stroke | at least 1 year after randomization | ischemic and hemorrhagic stroke |
Countries
South Korea
Outcome results
None listed