Atrial High Rate EpisodeNCT05475860
Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients
An observational study of Atrial High Rate Episode and Cardiac Implantable Electronic Device, run by Pusan National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial High Rate Episode, Cardiac Implantable Electronic Device
- What is being tested?
- implantable cardiac electronic device recipients
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2022to 31 Jul 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving cardiac implantable electronic device for any clinical indication (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy)
Who may be able to join
- patients receiving cardiac implantable electronic device
Who cannot join
- patients who disagree for blood sampling to analyze not commonly used clinical biomarkers
- patients not followed-up at least 12 months after implanting device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- implantable cardiac electronic device recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantable cardiac electronic device recipientsDevice
Also called pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy
implantable cardiac electronic device recipients for any clinical indication
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving cardiac implantable electronic device | Patients receiving cardiac implantable electronic device for any clinical indication Receives: Device: implantable cardiac electronic device recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of atrial high rate episode
Measured: 12 months
Secondary outcomes (1)
Factors predicting the occurrence of atrial high rate episode
factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start24 Jul 2022 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial High Rate EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinhee Ahn, MD, Pusan National University Hospital
- Investigators
- Jinhee Ahn, MD, Principal investigator, Clinical associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475860
- Sponsor's protocol ID
- H-1803
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers
- ClinicalTrials.gov ID
- NCT05475860
- Acronym / sponsor ID
- H-1803
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 24 Jul 2022 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving cardiac implantable electronic device | – | Device: implantable cardiac electronic device recipientsPatients receiving cardiac implantable electronic device for any clinical indication |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving cardiac implantable electronic device for any clinical indication (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy)
Key inclusion criteria (1 listed)
- patients receiving cardiac implantable electronic device
Key exclusion criteria (2 listed)
- patients who disagree for blood sampling to analyze not commonly used clinical biomarkers
- patients not followed-up at least 12 months after implanting device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantable cardiac electronic device recipientsAlso: pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapyimplantable cardiac electronic device recipients for any clinical indication | Device | Patients receiving cardiac implantable electronic device |
Primary outcome
The occurrence of atrial high rate episode
Time frame: 12 months
1 secondary outcome
Factors predicting the occurrence of atrial high rate episode
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial High Rate Episode
RecruitingObservational study
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
RecruitingPhase 4
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
Subclinical Atrial Fibrillation, Cardiac Arrhythmias
Not yet recruitingObservational study
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
Atrial Arrhythmia, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhee Ahn, MD principal investigator
Clinical associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial High Rate Episode and Cardiac Implantable Electronic Device, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinhee Ahn, MD (82-10-4840-5563, reinee7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of atrial high rate episode (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.