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NCT07294742

Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation

Sponsor: The Third People's Hospital of Chengdu

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate the safety and effectiveness of pulmonary vein isolation (PVI) and linear ablation using a large-focal pulsed field ablation (PFA) catheter in patients with persistent atrial fibrillation (perAF). The study will address two primary questions: 1. Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation? 2. Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping? Study Design and Intervention Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions. Participant Follow-up Protocol Enrolled participants will complete the following assessments: 1. Index Procedure: PVI and linear ablation with the PFApple PFA catheter. 2. Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability. 3. Clinical Follow-up: Scheduled visits at 7 days, 30 days, 3 months, 6 months, and 12 months post-procedure. Atrial tachyarrhythmia recurrence is assessed via 12-lead electrocardiography at each visit and 24-hour or 7-day Holter monitoring at the 6- and 12-month time points.

Official title: First-in-Human Experience Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-06

Completion Date

2026-06-15

Last Updated

2025-12-19

Healthy Volunteers

Conditions

Persistent Atrial Fibrillation

Interventions

DEVICE

a novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter

All patients underwent PVI via point-to-point wide antral circumferential ablation. Operators could optionally perform linear ablation (LAPW, MI, CTI, endpoint: bidirectional block). For MI ablation, coronary sinus adjunctive ablation was done for residual epicardial connections if needed. PVI, LAPW isolation, and MI ablation were reassessed 20 minutes later; additional ablation was performed until durable isolation/block. Persistent AF post-ablation was treated with electrical cardioversion. Post-PFA voltage maps were generated to characterize lesions.

Inclusion Criteria: 18 to 75 years with documented symptomatic PerAF (AF duration: 7 to 365 days), who were either refractory to or intolerant of at least one Class I or III antiarrhythmic drug and willing to provide informed consent. Exclusion Criteria: 1. Paroxysmal atrial fibrillation (AF) 2. AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies 3. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias 4. Patients with sustained ventricular tachycardia or ventricular fibrillation 5. Left atrial anteroposterior diameter \> 55 mm 6. Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation 7. History of left atrial ablation or cardiac surgery (including left atrial appendage closure) 8. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function) 9. Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities 10. Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities 11. Any of the following cardiac surgeries, implants, or conditions: * Prosthetic heart valve * NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 40% * Atrial septal defect or ventricular septal defect closure * Atrial myxoma, left atrial appendage device implantation or occlusion 12. History of any of the following within 3 months prior to the procedure: * Myocardial infarction * Unstable angina * Percutaneous coronary intervention * Cardiac surgery (including coronary artery bypass grafting) * Hospitalization for heart failure * Pericarditis 13. History of any of the following within 3 months prior to the procedure: * Cerebral infarction or transient ischemic attack (TIA) * Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \[TEE\]) 14. History of malignant tumor or expected life expectancy \< 12 months 15. Mental disorders or history of mental illness with inability to cooperate independently 16. Lactating, pregnant, or women planning or potentially becoming pregnant 17. Acute or severe systemic infection, or significant abnormalities in liver/renal function 18. Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator

Locations (1)

The Third People's Hospital of Chengdu

Chengdu, China