Rhythm control for device-detected AHREs in adults with no prior AF
Official title: National Tawan University Hospital
Run by National Taiwan University Hospital · NCT07649109 · Data updated 2026-11-12
This trial tests whether starting rhythm-control therapy plus risk-factor management helps people with device-detected AHREs lasting 6 minutes to 24 hours avoid progressing to clinical atrial fibrillation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07649109 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a cardiac implantable device and AHREs lasting 6 minutes to less than 24 hours, with no prior clinical AF.
✕Probably not a fit
Patients with AHREs already lasting 24 hours or with prior clinical AF, or those intolerant to rhythm-control therapy, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In adults with cardiac implantable devices, short bursts of rapid atrial rates (AHREs) may predict future atrial fibrillation and other heart problems. This randomized, open-label study compares an early rhythm-control strategy plus optimized risk-factor management against standard risk-factor care alone to see if it reduces progression to sustained AHREs or clinical AF. Participants have AHREs between 6 minutes and 24 hours and have not yet developed clinical AF. The trial uses a 1:1 randomization to the rhythm-control or usual-care arms and follows patients over time to monitor arrhythmia progression and clinical outcomes.
Why it matters
Potential benefit: If successful, early rhythm-control could slow or prevent progression to clinical AF and potentially reduce stroke risk and heart failure in this high-risk group.
How similar studies have gone: Prior observational data link shorter AHREs to progression, but randomized evidence on early rhythm-control in this exact AHRE range is limited, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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National Taiwan University Hospital
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: Hui-Chun Huang — National Taiwan University Hospital
- Study coordinator: Research Coordinator Huang
- Email: hchuangster@gmail.com
- Phone: +886-23123456
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.