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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
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.
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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.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 strokeevery 1 year upto 3 years after pacemaker implantation

Stroke based on device detected subclinical atrial fibrillation episodes

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine

🇰🇷

Seoul, Korea, Republic of

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