Ireland
--:--IST
Active, not recruiting Not applicable

Cyroablation for Pulmonary Vein Isolation Alone in Patients With Early Persistent AF Assessed by Continuous Monitoring

NCT05507749 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2020-11-27
Last updated
2026-08-20

Condition(s) studied

Atrial Fibrillation, Persistent

Investigational drug(s) / intervention(s)

cryoballoon ablationimplantable loop recorder insertion

cryoballoon ablation: Cryoballoon ablation for the treatment of atrial fibrillation

implantable loop recorder insertion: The device called a implantable loop recorder, is placed just under the skin of one's chest during a minor surgery.

Study summary

This study aimed to evaluate the efficacy of Cryoablation in patients with early persistent atrial fibrillation as a first index procedure using continuous cardiac rhythm monitoring.

Eligibility

Sex
ALL
Min age
20 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: * Drug refractory symptomatic persistent atrial fibrillation diagnosed within 3 years * Either two conditions 1. atrial fibrillation episode lasting longer than 7 days, but less than 3 years documented by consecutive electrocardiogram recordings of 100% atrial fibrillation greater than 7 days apart or 2. atrial fibrillation episode requiring electrical or pharmacological cardioversion after 24 hours of atrial fibrillation documented by continuous recording * Willing to comply with study requirements and give informed consent to participate in this clinical study Exclusion Criteria: * Long-standing persistent atrial fibrillation more than 3 years * Sinus rhythm at enrollment * Recurrent sinus rhythm after electrical cardioversion * Severe left ventricular dysfuncion (left ventricle ejection fraction \< 30%) * Previous ablation procedure or surgery for atrial fibrillation * Contraindication to chronic anticoagulation therapy or heparin * Documented left atrial diameter \>50 mm from parasternal long-axis view * A percutaneous coronary intervention or myocardial infarction ≤3 months * A stroke or transient ischemic attack ≤6 months * Planned cardiovascular intervention * Mental or physical inability to participate in the study * Participation in another randomized clinical trial * Uncontrolled hypertension, untreated hypothyroidism or hyperthyroidism * Requirement for dialysis due to terminal renal failure

Primary outcome measure(s)

  • Change of implantable cardiac monitor-detected atrial fibrillation/atrial flutter burden. — After cryoablation (between 3-month and 1-year) and pre-ablation
    The percentage of time spent in atrial fibrillation (hours of atrial fibrillation/hours of monitoring) during the first year after pulmonary vein isolation (excluding a 3-month window) compared to pre-ablation atrial fibrillation/atrial flutter burden.

Trial sites (1)

FacilityCityRegionStatus
Seoul National university Hostpital Seoul Jongno-gu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05507749 on ClinicalTrials.gov ↗ ← All trials in South Korea