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NCT07321002

PFLotus With the DePolar Mapping System in Patients With 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 efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical). The primary study objectives are to determine: * The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint). * The clinical effectiveness of the integrated PFA and mapping system. * The ability of the novel PFA system to produce durable ablation lesions. PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance. Participants will: 1. Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia; 2. Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure; 3. Undergo repeat electrophysiological mapping at 3 months to assess lesion durability; 4. Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.

Official title: Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-22

Completion Date

2027-07-31

Last Updated

2026-01-06

Healthy Volunteers

Conditions

Persistent Atrial Fibrillation

Interventions

DEVICE

Ablation with the PFLotus catheter and Depolar system

PVI and additional ablation strategies-including ablation of the left atrial posterior wall (LAPW), mitral isthmus (MI), cavotricuspid isthmus (CTI), and superior vena cava (SVC)-were performed in all patients with PerAF using the PFLotus PFA catheter and Depolar mapping system.

Inclusion Criteria: 1\. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment: 1. A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period. 2. Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF. 3\. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD). 4\. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written 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.