PFLotus shape-adaptive pulsed-field catheter for persistent atrial fibrillation

First-in-Human Experience Using a Novel Shape-Adaptive Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation

This trial tests a shape-changing pulsed-field catheter (PFLotus) to perform pulmonary vein isolation plus linear ablation in adults with persistent atrial fibrillation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Third People's Hospital of Chengdu (other)
• Locations: 1 site (Chengdu)
• Trial ID: NCT07301190 on ClinicalTrials.gov

What this trial studies

The PFLotus catheter can switch between a large 'petal' configuration for single‑shot pulmonary vein isolation and a small spherical 'bud' for focal or linear ablation, enabling a PVI‑plus strategy. Patients with persistent AF undergo PVI and additional linear lesions under general anesthesia using bipolar, biphasic pulsed‑field energy (850 V, 60 μs). The primary safety endpoint is absence of serious procedure- or device-related adverse events within 7 days, and durability of lesions is tested by remapping within three months after the index procedure. Enrollment required documented persistent AF and prior failure or intolerance of at least one class I or III antiarrhythmic drug, and all procedures were performed at the lead site in Chengdu.

Who should consider this trial

Good fit: Adults aged 18–75 with symptomatic persistent atrial fibrillation who have failed or cannot tolerate at least one class I or III antiarrhythmic drug and meet AF documentation criteria are ideal candidates.

Not a fit: Patients with paroxysmal AF, AF caused by electrolyte disorders, those outside the age range, or those unable to undergo general anesthesia are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could shorten procedure time and create durable lesions while reducing thermal injury to surrounding structures compared with traditional thermal ablation.

How similar studies have performed: Pulsed‑field ablation has shown promising safety and durable lesion signals in preclinical studies and early clinical use, but a catheter that switches between single‑shot and focal modes represents a novel first‑in‑human approach.

Eligibility criteria

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

Where this trial is running

Chengdu

• The Third People's Hospital of Chengdu — Chengdu, China (RECRUITING)

Study contacts

• Study coordinator: Shiqiang Xiong, Doctor of Medicine

Conditions: Persistent Atrial Fibrillation, persistent atrial fibrillation, pulmonary vein isolation, ablation time, procedure time, freedom from atrial tachyarrhythmia recurrence, cavotricuspid isthmus ablation, mitral isthmus ablation