Persistent atrial fibrillation
Conditions
Interventions
Cryoballoon group
PulseSelect group
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with persistent atrial fibrillation scheduled to undergo catheter ablation treatment. Persistent atrial fibrillation is defined, according to relevant guidelines, as atrial fibrillation that persists for up to one year, or cases requiring antiarrhythmic drugs or electrical cardioversion. Indications for catheter ablation will follow the Guidelines for Non-Pharmacotherapy of Arrhythmias (2018 revision) and the Focused Update of the Arrhythmia Treatment Guidelines (2024) issued by the Japanese Circulation Society and the Japanese Heart Rhythm Society. Patients aged between 18 and 85 years at the time of consent. Patients capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: Patients with paroxysmal atrial fibrillation. Patients with long-standing persistent atrial fibrillation lasting more than one year. Patients who have previously undergone catheter ablation or surgical ablation. Patients with a left atrial diameter greater than 55 mm. Patients for whom cryoballoon ablation or pulsed field ablation is not suitable: --Patients judged unable to receive contrast media due to conditions such as chronic kidney disease, bronchial asthma, or contrast agent allergy (contrast media is required for cryoballoon ablation). Any other patients deemed unsuitable by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Efficacy Endpoints Efficacy will be assessed using the following composite endpoints: Recurrence of atrial tachyarrhythmia: Recurrence is defined as any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or more within one year after a 90-day post-procedure blanking period, or the need for repeat ablation. Assessment will be conducted using 24-hour Holter monitoring at 6 and 12 months. Additionally, arrhythmias detected on 12-lead ECGs during emergency visits for palpitations will also be included. Acute procedural failure: If the treatment cannot be completed using only the cryoballoon catheter or the pulsed field ablation catheter and requires additional devices (e.g., radiofrequency ablation catheters), it will be considered a procedural failure. 2) Safety Endpoints The incidence of procedure-related complications occurring during the procedure or within 30 days postoperatively will be assessed. The perioperative period is defined as within 30 days after the procedure, during which the following complications will be evaluated: air embolism during the procedure, cardiac tamponade, cerebral infarction (including TIA), systemic embolism, vascular complications, phrenic nerve palsy, esophageal complications, and gastric peristalsis disorders. Secondary Endpoints 1) Differences in left atrial diameter reduction (preoperative, 6 months, and 12 months postoperatively) 2) Changes in blood biomarkers such as BNP and NT-proBNP (preoperative, 6 months, and 12 months postoperatively) 3) Relationship between atrial arrhythmia recurrence during the blanking period and recurrence in the late phase 4) Evaluation of subjective symptoms on the day after the procedure using the Numeric Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 to 10 used to self-assess pain and discomfort, where 0 indicates no pain and 10 indicates the worst pain imaginable. | — |
Countries
Japan
Contacts
Public ContactHidehira Fukaya
Kitasato University School of Medicine Cardiovascular Medicine
Outcome results
None listed