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

July 24, 2022 updated by: Jinhee Ahn, MD, Pusan National University Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving cardiac implantable electronic device for any clinical indication (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving cardiac implantable electronic device
Patients receiving cardiac implantable electronic device for any clinical indication
Device: implantable cardiac electronic device recipients
implantable cardiac electronic device recipients for any clinical indication
Other Names:
  • pacemaker
  • implantable cardioverter-defibrillator
  • cardiac resynchronization therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of atrial high rate episode
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Jinhee Ahn, MD, Clinical Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 24, 2022

Primary Completion (ANTICIPATED)

February 28, 2024

Study Completion (ANTICIPATED)

July 31, 2024

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (ACTUAL)

July 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • H-1803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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