FIH Study of PFLotus in Persistent Atrial Fibrillation

NCT07301190 | Recruiting

• 1 other identifier: PFLotus- FIH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there an absence of serious procedure or device-related adverse events within 7 days?
2. 2.Can the catheter achieve durable lesions?
3. 3.Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia;
4. 4.Undergo remapping within 3-month post the index ablation to assess the durability of the lesions;
5. 5.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.

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; pulmonary vein isolation; ablation time; procedure time; freedom from atrial tachyarrhythmia recurrence; cavotricuspid isthmus ablation; mitral isthmus ablation; coronary sinus

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint

  The primary safety endpoint was the incidence of primary adverse events (PAEs) within 7 days post-ablation. Later-occurring events (device/procedure-related death, atrio-esophageal fistula, PV stenosis) were also classified as PAEs. Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months were considered PAEs.

  Seven days post index ablation procedure

• The primary efficacy endpoint

  The primary efficacy endpoint was acute procedural success, defined as the proportion of patients achieving: 1) complete electrical isolation of all PVs, and 2) for those undergoing linear ablation, confirmed bidirectional block at all targeted sites (LAPW, MI, CTI).

  Immediately after the index ablation procedure

Secondary Outcomes (4)

• Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]

  Immediate after the index ablation procedure

• Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]

  Immediate after the index ablation procedure

• Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint]

  3 months after the index ablation procedure

• 1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]

  1 year after the index ablation procedure

Study Arms (1)

Ablation Group

EXPERIMENTAL

PVI was performed in all patients. Additional linear ablation strategies Including the left atrial posterior wall (LAPW), mitral isthmus (MI), or cavotricuspid isthmus (CTI), were performed at the operator's discretion.

Device: Pulse field ablation with the PFLotus catheter

Interventions

Pulse field ablation with the PFLotus catheter DEVICE

PVI was performed in all patients. Additional linear ablation strategies Including the left atrial posterior wall (LAPW), mitral isthmus (MI), or cavotricuspid isthmus (CTI), were performed at the operator's discretion.

Ablation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
• Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.
• \. 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.
• \. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.

You may not qualify if:

• Paroxysmal atrial fibrillation (AF)
• AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
• Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
• Patients with sustained ventricular tachycardia or ventricular fibrillation
• Left atrial anteroposterior diameter \> 55 mm
• Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation
• History of left atrial ablation or cardiac surgery (including left atrial appendage closure)
• 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)
• Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities
• Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities
• 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

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Study Sites (1)

The Third People's Hospital of Chengdu

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Shiqiang Xiong, Doctor of Medicine

CONTACT

8619980510703; xionglliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 24, 2025
• Study Start: June 11, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2-year post primary publication
• Access Criteria: 1. Eligible Recipients: Qualified researchers with academic/institutional affiliation, who submit a feasible research proposal and agree to comply with data protection regulations. Accessible MaterialsDe-identified individual participant data (baseline, procedural, follow-up data related to PFA/AF) and supporting documents (study protocol, statistical analysis plan, redacted clinical study report). Identifiable information and raw imaging data are excluded. 2. Access Process Submit application (proposal, CV, IRB approval, signed DUA) to the corresponding author via designated email.

Locations

CN (1)