Status:
UNKNOWN
Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
Lead Sponsor:
Yonsei University
Conditions:
Post Pacemaker Implantation Patients
Eligibility:
All Genders
18-80 years
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 occ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT03303872
Start Date
December 31 2017
End Date
December 31 2022
Last Update
June 20 2018
Active Locations (1)
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1
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722