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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03303872

Enrollment

900

Registered

2017-10-06

Start date

2017-12-31

Completion date

2022-12-31

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Pacemaker Implantation Patients

Keywords

atrial high rate episode, pacemaker, atrial fibrillation, stroke

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of subclinical atrial fibrillation (atrial high rate episode)	3 months after pacemaker implantation	—
Occurrence of stroke	3 months after pacemaker implantation	Stroke based on device detected subclinical atrial fibrillation episodes

Countries

South Korea

Contacts

Primary ContactBoyoung Joung, M.D., Ph.D.

CBY6908@yuhs.ac82-10-8025-0424

Outcome results