Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
- Conditions
- Post Pacemaker Implantation Patients
- Registration Number
- NCT03303872
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of subclinical atrial fibrillation (atrial high rate episode) every 1 year upto 3 years after pacemaker implantation Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant
Occurrence of stroke every 1 year upto 3 years after pacemaker implantation Stroke based on device detected subclinical atrial fibrillation episodes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of