Clinical trial NCT03303872: Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
Official title: Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Pacemaker Implantation Patients
Keywords: atrial high rate episode
pacemaker
atrial fibrillation
stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients post pacemaker implantation

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.


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.

Primary outcomes:
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
timeFrame: 3 months after pacemaker implantation
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
timeFrame: 6 months after pacemaker implantation
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
timeFrame: every 1 year upto 3 years after pacemaker implantation
measure: Occurrence of stroke
timeFrame: 3 months after pacemaker implantation
measure: Occurrence of stroke
timeFrame: 6 months after pacemaker implantation
measure: Occurrence of stroke
timeFrame: every 1 year upto 3 years after pacemaker implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Kim M, Kim TH, Yu HT, Choi EK, Park HS, Park J, Lee YS, Kang KW, Shim J, Sung JH, Oh IY, Joung B; AF-Pacemaker Study Group. Prevalence and Predictors of Clinically Relevant Atrial High-Rate Episodes in Patients with Cardiac Implantable Electronic Devices. Korean Circ J. 2021 Mar;51(3):235-247. doi: 10.4070/kcj.2020.0393.