Biomarkers Predicting Atrial High Rate Episodes in Cardia... | NCT05475860

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

NCT05475860

Sponsor

Pusan National University Hospital

Status

Unknown status

Last Update Posted

Jul 27, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial High Rate Episode
Cardiac Implantable Electronic Device

Interventions

implantable cardiac electronic device recipients

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2022Estimated

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Jul 24, 2022

First Submission Date that Met QC Criteria

Jul 24, 2022

First Posted Date

Jul 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2022

Last Update Posted Date

Jul 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinhee Ahn, MD, Clinical associate professor, Pusan National University HospitalPrincipal Investigator

Lead Sponsor

Pusan National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving cardiac implantable electronic device		Patients receiving cardiac implantable electronic device for any clinical indication	Device: implantable cardiac electronic device recipients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implantable cardiac electronic device recipients	Device	implantable cardiac electronic device recipients for any clinical indication	Patients receiving cardiac implantable electronic device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinhee Ahn, MD	Contact	82-10-4840-5563		reinee7@gmail.com

Overall Officials

Name	Affiliation	Role
Jinhee Ahn, MD	Clinical associate professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinhee Ahn		Busan			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017147	Defibrillators, Implantable
D058406	Cardiac Resynchronization Therapy

Ancestor Terms

ID	Term
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

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Browse Branches

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