Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients

• Conditions: Atrial High Rate Episode; Cardiac Implantable Electronic Device
• Interventions: Device: implantable cardiac electronic device recipients

• Registration Number: NCT05475860
• Lead Sponsor: Pusan National University Hospital

Brief Summary

This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).

Detailed Description

Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-24
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Last Update Submitted: 2022-07-24
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-27
• Primary Completion: 2024-02-28
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients receiving cardiac implantable electronic device

Exclusion Criteria

• patients who disagree for blood sampling to analyze not commonly used clinical biomarkers
• patients not followed-up at least 12 months after implanting device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving cardiac implantable electronic device	implantable cardiac electronic device recipients	Patients receiving cardiac implantable electronic device for any clinical indication

Primary Outcome Measures

Name	Time	Method
The occurrence of atrial high rate episode	12 months

Secondary Outcome Measures

Name	Time	Method
Factors predicting the occurrence of atrial high rate episode	12 months	factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism

Trial Locations

Locations (1)

Jinhee Ahn; 🇰🇷 Busan, Korea, Republic of