Subclinical Atrial FibrillationPhase 4AHRENCT07649109
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
A Phase 4 study of Subclinical Atrial Fibrillation and Cardiac Arrhythmias, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclinical Atrial Fibrillation, Cardiac Arrhythmias
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Age ≥18 years. Presence of a cardiac implantable electronic device (CIED), including permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
Device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes and <24 hours.
Ability to provide written informed consent. Willingness and ability to comply with study procedures and follow-up visits. Exclusion Criteria Prior diagnosis of clinical atrial fibrillation, atrial flutter, or atrial tachycardia requiring treatment.
Device-detected AHRE ≥24 hours before enrollment. Current treatment with class I or class III antiarrhythmic drugs for atrial arrhythmias.
Previous catheter ablation for atrial fibrillation or atrial flutter. Planned catheter ablation within the next 3 months. Contraindication to rhythm-control therapy as determined by the treating physician.
Life expectancy less than 1 year. Severe comorbid illness that may interfere with study participation or follow-up.
Pregnancy or breastfeeding. Participation in another interventional clinical trial that may affect study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Official title: National Tawan University Hospital
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality. However, optimal management strategies for patients with AHREs lasting between 6 minutes and 24 hours remain uncertain. Current guidelines recommend risk factor modification, but the role of early rhythm-control therapy in preventing AHRE progression has not been well established.
This prospective, randomized, open-label study aims to evaluate whether a rhythm-control strategy combined with optimal risk factor management can reduce progression to sustained AHREs (≥24 hours) or clinical AF compared with optimal risk factor management alone in patients with device-detected AHREs. Eligible participants with CIED-detected AHREs lasting 6 minutes to 24 hours and without prior clinical AF will be randomly assigned to either a rhythm-control group or a usual-care group. The primary endpoint is progression to AHRE duration ≥24 hours or documented clinical AF. Secondary endpoints include stroke, systemic embolism, heart failure hospitalization, cardiovascular death, and all-cause mortality.
Read the detailed description
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are increasingly recognized as an early stage of atrial fibrillation (AF) and are associated with an elevated risk of AF progression, stroke, heart failure, and mortality. However, the optimal management of patients with device-detected AHREs remains uncertain, particularly for individuals with episodes lasting between 6 minutes and 24 hours. Current management strategies generally focus on risk factor modification and clinical surveillance, while evidence supporting early rhythm-control intervention in this population is limited.
Observational studies have demonstrated that progression from shorter-duration AHREs to sustained AHREs (≥24 hours) is associated with substantially worse clinical outcomes and may represent an important stage in the evolution of atrial cardiomyopathy. Preventing progression of AHREs may therefore provide an opportunity to alter the natural history of AF and reduce future cardiovascular complications.
This prospective, randomized, open-label, controlled trial is designed to evaluate whether an early rhythm-control strategy can reduce progression of device-detected AHREs compared with usual care. Eligible participants are adults with CIED-detected AHREs lasting between 6 minutes and 24 hours and without a prior diagnosis of clinical atrial fibrillation. Participants will be randomly assigned in a 1:1 ratio to either a rhythm-control strategy or usual care.
The rhythm-control strategy may include antiarrhythmic drug therapy, catheter ablation, or other guideline-directed rhythm-control interventions at the discretion of the treating physician. Both groups will receive comprehensive management of cardiovascular risk factors according to contemporary clinical practice guidelines.
The primary endpoint is a composite of progression to sustained AHREs (≥24 hours) or development of clinically documented atrial fibrillation during follow-up. Secondary endpoints include changes in AHRE burden, ischemic stroke, systemic embolism, heart failure hospitalization, cardiovascular death, all-cause mortality, and treatment-related adverse events.
Participants will undergo regular device interrogation and clinical follow-up throughout the study period. The study aims to determine whether early rhythm-control intervention can delay AF progression and improve long-term cardiovascular outcomes in patients with device-detected AHREs.
- Being tested
- Early Rhythm Control Strategy, Usual Care
- Keywords
- Atrial High-Rate Episodes (AHRE), Cardiac Implantable Electronic Device, Early Rhythm Control
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Rhythm Control StrategyOther
Participants assigned to the early rhythm-control strategy will receive antiarrhythmic drug therapy according to contemporary clinical practice guidelines and physician discretion. Comprehensive cardiovascular risk factor management will be provided throughout the study.
Usual CareOther
Standard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm Control Strategy | Experimental | Participants will receive an early rhythm-control strategy including antiarrhythmic drug therapy, in addition to comprehensive cardiovascular risk factor management. Receives: Other: Early Rhythm Control Strategy |
| Arm2 (Usual care) | Active comparator | Participants will receive standard clinical care and cardiovascular risk factor management according to contemporary clinical practice guidelines. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to Sustained AHRE or Clinical Atrial Fibrillation
Composite endpoint of progression to device-detected atrial high-rate episodes lasting 24 hours or longer, or development of clinically documented atrial fibrillation confirmed by electrocardiography, ambulatory rhythm monitoring, or physician-adjudicated rhythm recordings.
Measured: Up to 36 months
Secondary outcomes (3)
Ischemic Stroke or Systemic Embolism
Ischemic Stroke or Systemic Embolism
Measured: Up to 36 months
Cardiovascular Death
Cardiovascular Death
Measured: 36 months
Heart Failure Hospitalization
Heart Failure Hospitalization
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Chun Huang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649109
- Sponsor's protocol ID
- 202503151MINC
- Acronym
- AHRE
- Status last verified
- May 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications, including demographic characteristics, baseline clinical variables, device interrogation data, and outcome measures, will be made available upon reasonable request to the corresponding investigator after publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tawan University Hospital
- ClinicalTrials.gov ID
- NCT07649109
- Acronym / sponsor ID
- AHRE / 202503151MINC
- Keywords
- Atrial High-Rate Episodes (AHRE), Cardiac Implantable Electronic Device, Early Rhythm Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (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.
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality. However, optimal management strategies for patients with AHREs lasting between 6 minutes and 24 hours remain uncertain. Current guidelines recommend risk factor modification, but the role of early rhythm-control therapy in preventing AHRE progression has not been well established.
This prospective, randomized, open-label study aims to evaluate whether a rhythm-control strategy combined with optimal risk factor management can reduce progression to sustained AHREs (≥24 hours) or clinical AF compared with optimal risk factor management alone in patients with device-detected AHREs. Eligible participants with CIED-detected AHREs lasting 6 minutes to 24 hours and without prior clinical AF will be randomly assigned to either a rhythm-control group or a usual-care group. The primary endpoint is progression to AHRE duration ≥24 hours or documented clinical AF. Secondary endpoints include stroke, systemic embolism, heart failure hospitalization, cardiovascular death, and all-cause mortality.
Detailed description
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are increasingly recognized as an early stage of atrial fibrillation (AF) and are associated with an elevated risk of AF progression, stroke, heart failure, and mortality. However, the optimal management of patients with device-detected AHREs remains uncertain, particularly for individuals with episodes lasting between 6 minutes and 24 hours. Current management strategies generally focus on risk factor modification and clinical surveillance, while evidence supporting early rhythm-control intervention in this population is limited.
Observational studies have demonstrated that progression from shorter-duration AHREs to sustained AHREs (≥24 hours) is associated with substantially worse clinical outcomes and may represent an important stage in the evolution of atrial cardiomyopathy. Preventing progression of AHREs may therefore provide an opportunity to alter the natural history of AF and reduce future cardiovascular complications.
This prospective, randomized, open-label, controlled trial is designed to evaluate whether an early rhythm-control strategy can reduce progression of device-detected AHREs compared with usual care. Eligible participants are adults with CIED-detected AHREs lasting between 6 minutes and 24 hours and without a prior diagnosis of clinical atrial fibrillation. Participants will be randomly assigned in a 1:1 ratio to either a rhythm-control strategy or usual care.
The rhythm-control strategy may include antiarrhythmic drug therapy, catheter ablation, or other guideline-directed rhythm-control interventions at the discretion of the treating physician. Both groups will receive comprehensive management of cardiovascular risk factors according to contemporary clinical practice guidelines.
The primary endpoint is a composite of progression to sustained AHREs (≥24 hours) or development of clinically documented atrial fibrillation during follow-up. Secondary endpoints include changes in AHRE burden, ischemic stroke, systemic embolism, heart failure hospitalization, cardiovascular death, all-cause mortality, and treatment-related adverse events.
Participants will undergo regular device interrogation and clinical follow-up throughout the study period. The study aims to determine whether early rhythm-control intervention can delay AF progression and improve long-term cardiovascular outcomes in patients with device-detected AHREs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Rhythm Control Strategy | Experimental | Other: Early Rhythm Control StrategyParticipants will receive an early rhythm-control strategy including antiarrhythmic drug therapy, in addition to comprehensive cardiovascular risk factor management. |
| Arm2 (Usual care) | Active comparator | Other: Usual CareParticipants will receive standard clinical care and cardiovascular risk factor management according to contemporary clinical practice guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Early Rhythm Control StrategyParticipants assigned to the early rhythm-control strategy will receive antiarrhythmic drug therapy according to contemporary clinical practice guidelines and physician discretion. Comprehensive cardiovascular risk factor management will be provided throughout the study. | Other | Rhythm Control Strategy |
| Usual CareStandard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy. | Other | Arm2 (Usual care) |
Primary outcome
Progression to Sustained AHRE or Clinical Atrial Fibrillation
Time frame: Up to 36 months
Composite endpoint of progression to device-detected atrial high-rate episodes lasting 24 hours or longer, or development of clinically documented atrial fibrillation confirmed by electrocardiography, ambulatory rhythm monitoring, or physician-adjudicated rhythm recordings.
3 secondary outcomes
Ischemic Stroke or Systemic Embolism
Time frame: Up to 36 months
Cardiovascular Death
Time frame: 36 months
Heart Failure Hospitalization
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications, including demographic characteristics, baseline clinical variables, device interrogation data, and outcome measures, will be made available upon reasonable request to the corresponding investigator after publication of the primary study results.
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Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
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Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation
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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.
Hui-Chun Huang principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Subclinical Atrial Fibrillation and Cardiac Arrhythmias, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator Huang (+886-23123456, hchuangster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to Sustained AHRE or Clinical Atrial Fibrillation (time frame: Up to 36 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 16 Jun 2026.