Paroxysmal Atrial Fibrillation (PAF)
Conditions
Brief summary
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
Interventions
PROCEDUREPercutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
PROCEDUREPatients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
Sponsors
China National Center for Cardiovascular Diseases
Hangzhou Dinova EP Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 to 75 years (including 18 years and 75 years of age). * Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation. * Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion criteria
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes; * Previous history of catheter ablation or cardiac surgery for atrial fibrillation; * Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair; * Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials; * Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.); * Persistent atrial fibrillation; * Left atrial anteroposterior diameter (LAD) \> 55 mm on transthoracic echocardiography; * Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial; * Current participation in another pharmaceutical or medical device clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of complete electrical isolation of pulmonary veins during the procedure | Immediately post-procedure | The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure. | 12 months post-procedure | The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure. |
| The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure | 12 months post-procedure | The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure. |
| The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure | 12 months post-procedure | The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure |
| The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period | From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure | The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period |
| Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline | 12 months post-procedure | The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels |
| Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups. | Immediately post-procedure | Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups. |
| Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups. | through study completion, an average of 1 year | After hospital discharge, the length of hospital stay for this admission and the duration of postoperative observation in CCU/ICU were compared between the two groups of patients. |
| Compare the procedural time and DSA fluoroscopy time between the two groups. | Immediately post-procedure | Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups. |
| Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses. | through study completion, an average of 1 year | Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge. |
| Success rate of atrial fibrillation ablation at 12 months post-procedure. | 12 months post-procedure | Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation) |
| The incidence of complications within 30 days after the procedure | Within 30 days post-procedure | Observe the proportion of complications occurring within 30 days after the procedure. Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death. |
Contacts
CONTACTMIN TANG, Doctor
Outcome results
None listed