The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.

NCT07649109 | Recruiting Phase 4 DMC

• 1 other identifier: 202503151MINC
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subclinical Atrial Fibrillation; Cardiac Arrhythmias

Keywords

Atrial High-Rate Episodes (AHRE); Cardiac Implantable Electronic Device; Early Rhythm Control

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 36 months

Secondary Outcomes (3)

• Ischemic Stroke or Systemic Embolism

  Up to 36 months

• Cardiovascular Death

  36 months

• Heart Failure Hospitalization

  36 months

Study Arms (2)

Rhythm Control Strategy

EXPERIMENTAL

Participants will receive an early rhythm-control strategy including antiarrhythmic drug therapy, in addition to comprehensive cardiovascular risk factor management.

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.

Other: Usual Care

Interventions

Early Rhythm Control Strategy OTHER

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.

Rhythm Control Strategy

Usual Care OTHER

Standard clinical management and cardiovascular risk factor management according to contemporary clinical practice guidelines without a protocol-mandated rhythm-control strategy.

Arm2 (Usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes and \<24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Chun Huang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator Huang

CONTACT

+886-23123456; hchuangster@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Data will be available to qualified researchers whose proposed use of the data has been approved by the study investigators. Requests should be directed to the corresponding investigator. A data use agreement may be required.

Locations

TW (1)