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The optimal strategy for treating persistent atrial fibrillation with radiofrequency catheter ablation (a randomized controlled trial)

Biatrial catheter ablation versus Pulmonary vein isolation alone for patients with persistent atrial fibrillation: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0008560
Enrollment
240
Registered
2023-06-27
Start date
2023-06-30
Completion date
Unknown
Last updated
2023-08-01

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

Conditions

None listed

Interventions

Procedure/Surgery : (1) The bi-atrial ablation group --> underwent additional ablation of the right atrium after pulmonary vein isolation. This additional ablation may decrease the recurrence rate of

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults between the ages of 18 and 85 Diagnosis of persistent atrial fibrillation, which is confirmed by 12-lead electrocardiogram or Holter monitoring lasting for more than 7 days, event recorder, or exercise stress test Resistance or intolerance to at least one class I or III antiarrhythmic drug Patients undergoing the first eablation procedure for atrial fibrillation Patients who have provided informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who refuse to participate in the study Patients under 18 or over 85 years of age Left atrial diameter of 60mm or greater Atrial thrombus Contraindication to anticoagulation therapy Previous surgical or procedural treatment for atrial fibrillation Severe valvular heart disease, mitral stenosis, or mechanical prosthetic valve Left atrial diameter of 60mm or greater NYHA class IV heart failure Recent thoracic surgery within the past 3 months Scheduled thoracic surgery within the next 3 months Pulmonary veins observed on CT that are anatomically unsuitable for the procedure End-stage or severe heart failure (estimated glomerular filtration rate [MDRD method] < 30mL/min/1.73m) Pregnant or breastfeeding women NYHA class IV heart failure Acute coronary syndrome within the past 3 months Patients with a life expectancy of less than 1 year.

Design outcomes

Primary

MeasureTime frame
The incidence of atrial tachyarrhythmia, including atrial fibrillation, atrial flutter, and atrial tachycardia, lasting for 30 seconds or longer, that occurs after a blanking period of several months and while the medication is discontinued.

Secondary

MeasureTime frame
Occurrence of atrial fibrillation confirmed by electrocardiogram lasting more than 30 seconds within 1 year after a blanking period of 3 months following the procedure, regardless of medication use.;Occurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting more than 30 seconds within 1 year after a blanking period of 3 months following the procedure, regardless of medication use.;Occurrence of any type of atrial tachyarrhythmia lasting more than 30 seconds within 1 year after a blanking period of 3 months following the procedure, regardless of medication use.;Occurrence of any type of atrial tachyarrhythmia lasting more than 30 seconds within 1 year after a blanking period of 3 months following the procedure, whether confirmed by electrocardiogram or not.;Occurrence of hemodynamically unstable;pacemaker implantation;Occurrence of any type of atrial tachyarrhythmia during the 3-month blanking period following the procedure.;Occurrence of complications before and after the procedure (such as stroke, cardiac tamponade, pulmonary vein stenosis, esophageal injury, death).;Ratio of successful "first-pass isolation" or "first-freeze isolation" procedures.;Duration of the procedure (in minutes), Duration of radiation exposure (in minutes).;Number of repeat procedures required.;Success rate of linear ablation if performed.;Sinus rhythm maintenance at 6-month and 12-month

Countries

Korea, Republic of

Contacts

Public ContactMyung-Jin Cha

Asan Medical Center

mjcha@amc.seoul.kr+82-2-3010-3321

Outcome results

None listed

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