NCT07649109RecruitingPhase 4
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
National Tawan University Hospital
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07649109
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 450
- From 1 Oct 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.