NCT05475860

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

July 24, 2022

Last Update Submit

July 24, 2022

Conditions

Atrial High Rate EpisodeCardiac Implantable Electronic Device

Outcome Measures

Primary Outcomes (1)

  • The occurrence of atrial high rate episode

    12 months

Secondary Outcomes (1)

  • Factors predicting the occurrence of atrial high rate episode

    12 months

Study Arms (1)

Patients receiving cardiac implantable electronic device

Patients receiving cardiac implantable electronic device for any clinical indication

Device: implantable cardiac electronic device recipients

Interventions

implantable cardiac electronic device recipientsDEVICE

implantable cardiac electronic device recipients for any clinical indication

Also known as: pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy
Patients receiving cardiac implantable electronic device

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients receiving cardiac implantable electronic device

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinhee Ahn

Busan, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

biomarkers including soluble ST-2 and FGF-23, single nucleotide polymorphism

MeSH Terms

Interventions

Defibrillators, ImplantableCardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and ImplantsCardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Jinhee Ahn, MD

    Clinical associate professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhee Ahn, MD

CONTACT

82-10-4840-5563reinee7@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 27, 2022

Study Start

July 24, 2022

Primary Completion

February 28, 2024

Study Completion

July 31, 2024

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)