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Efficacy of early rhythm control therapy in patients with subclinical atrial fibrillation

Efficacy of early rhythm control therapy in patients with subclinical atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009027
Enrollment
520
Registered
2023-12-08
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Procedure/Surgery : As soon as AHRE is detected and assigned to the randomized group, the early rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. Th

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found - Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT) 1) Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together) 2) If the accumulated period of the atrial high rate episode during the three-month observation period is more than 24 hours 3) Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected However, enrollment is possible even if it includes one of the following two cases ? Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring ? If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds

Exclusion criteria

Exclusion criteria: 1) Patients deemed inappropriate to participate in the study by the investigator 2) Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study 3) Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation 4) Patients who have had rhythm control treatments such as Radiofequency catheter ablation (RFCA), Total thoracoscopic ablation (TTA), Maze procedure (MAZEop), and antiarrhythmic treatment due to atrial fibrillation (except for CTI ablation with AFL) 5) Patients whose life expectancy is less than one year (e.g., patients who can't even have a heart transplant, patients who receive DNR, Patients in hospice wards who refuse life-sustaining treatment, terminal cancer patients who cannot receive radiation or chemotherapy, etc.)

Design outcomes

Primary

MeasureTime frame
decrease in atrial fibrillation burden by less than 50% or incidence of clinical AF documentation;side effects related to medication or other treatments

Secondary

MeasureTime frame
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation;Left ventricular function change, BNP change, AFEQT (quality of life assessment), MoCA (cognitive function assessment)

Countries

Korea, Republic of

Contacts

Public ContactMinjeong Kwon

Samsung Medical Center

gms06261@naver.com+82-2-2148-7611

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026