FIH Study of PFLotus in Persistent Atrial Fibrillation

Summary

Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF). The main questions it aims to answer are: 1. Is there an absence of serious procedure or device-related adverse events within 7 days? 2. Can the catheter achieve durable lesions? This trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical). Participants will: 1. Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia; 2. Undergo remapping within 3-month post the index ablation to assess the durability of the lesions; 3. Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.

Eligibility

Inclusion Criteria:

1\. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets \*\*any one\*\* of the following criteria:

1. A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
2. Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.

3\. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs.

4\. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.

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

Conditions2

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