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

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.

Study Overview

• Status: Unknown
• Conditions: Post Pacemaker Implantation Patients

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Boyoung Joung, M.D., Ph.D.; Phone Number: 82-10-8025-0424; Email: CBY6908@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Boyoung Joung, M.D., Ph.D.; Phone Number: 82-10-8025-0424; Email: CBY690@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients post pacemaker implantation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
AF-pacemaker registry

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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; pacemaker; atrial high rate episode
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrial Fibrillation; Atrioventricular Block
• Other Study ID Numbers: 1-2017-0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No