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

Cardiac Implantable Electronic Device Clinical Trial

Official title:

Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05475860
• Other study ID #: H-1803
• Status: Not yet recruiting
• Start date: July 24, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2022
• Source: Pusan National University Hospital
• Contact: Jinhee Ahn, MD
• Phone: 82-10-4840-5563
• Email: reinee7[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device

Intervention

Device:
• implantable cardiac electronic device recipients
implantable cardiac electronic device recipients for any clinical indication

Locations

Country	Name	City	State
Korea, Republic of	Jinhee Ahn	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of atrial high rate episode		12 months
Secondary	Factors predicting the occurrence of atrial high rate episode	factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism	12 months