The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Dev… (NCT07649109) | Clinical Trial Compass
RecruitingPhase 4
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
Taiwan450 participantsStarted 2025-10-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My cardiac device has already detected abnormal heart rhythm activity — does the fact that this trial is focused specifically on device-detected 'subclinical' atrial fibrillation (AF that I may not feel but the device picks up) mean it could give my care team more information about what my readings actually mean for my long-term health?
2This is a Phase 4 trial, which I understand means the treatments being studied are already approved — so what specifically is this study trying to learn that isn't already known, and how might that affect decisions about my own treatment?
3The trial is measuring whether subclinical atrial fibrillation progresses to more sustained or clinical AF — does that mean there's still uncertainty about whether what my device is detecting will become a bigger problem, and how are you currently deciding whether I need treatment while that question is open?
4What would my involvement in this trial actually look like day-to-day — would I need extra monitoring visits, device checks, or medication changes beyond what I'd have in routine care?
5Given that there are established guidelines for managing atrial fibrillation already, would you recommend I consider standard care first, or is participating in this trial something that could genuinely help guide my treatment in a way that routine care alone wouldn't?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression to Sustained AHRE or Clinical Atrial Fibrillation