Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)

Study Overview
=================
Brief Summary
-----------------
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.

Official Title
-----------------
Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)

Conditions
-----------------
Post Pacemaker Implantation Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) Life expectancy < 12 months Patients unable or unwilling to cooperate in the study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AF-pacemaker registry<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of subclinical atrial fibrillation (atrial high rate episode) |  | 3 months after pacemaker implantation | 
| Occurrence of subclinical atrial fibrillation (atrial high rate episode) |  | 6 months after pacemaker implantation | 
| Occurrence of subclinical atrial fibrillation (atrial high rate episode) | Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant | every 1 year upto 3 years after pacemaker implantation | 
| Occurrence of stroke | Stroke based on device detected subclinical atrial fibrillation episodes | 3 months after pacemaker implantation | 
| Occurrence of stroke | Stroke based on device detected subclinical atrial fibrillation episodes | 6 months after pacemaker implantation | 
| Occurrence of stroke | Stroke based on device detected subclinical atrial fibrillation episodes | every 1 year upto 3 years after pacemaker implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial high rate episode, pacemaker, atrial fibrillation, stroke