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

NCT07294742 | Active Not Recruiting

• 1 other identifier: PFApple for PerAF
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation?
2. 2.Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping?
3. 3.Index Procedure: PVI and linear ablation with the PFApple PFA catheter.
4. 4.Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability.
5. 5.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.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; pulse field ablation; pulmonary vein isolation; posterior wall ablation; mitral isthmus; tricuspid isthmus

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint

  The primary safety endpoint of this pilot study was the occurrence of primary adverse events within 7 days after the index ablation procedure. Device- or procedure-related death, atrio-oesophageal fistula, and PV stenosis occurring more than 7 days post-ablation were also classified as primary adverse events. Diaphragmatic paralysis/phrenic nerve palsy were considered PAEs if symptoms persisted at the 3-month follow-up visit.

  3 months post-ablation

• The primary efficacy endpoint

  The primary efficacy endpoint was the acute procedural success rate, defined as the proportion of patients who achieved all of the following: 1) complete electrical isolation of all PVs after PVI; 2) for patients undergoing additional linear ablation, bidirectional block confirmed at the targeted linear sites (LAPW, MI, or CTI).

  Immediately post-ablation

Secondary Outcomes (1)

• The secondary efficacy endpoints

  One year post-ablation

Study Arms (1)

Ablation group

EXPERIMENTAL

All patients underwent PVI via point-to-point wide antral circumferential ablation (20-30 points, inter-point distance ≤10 mm) targeting 1-2 mm outside PV ostia (confirmed by angiography/3D mapping) to ensure contiguous, transmural lesions. Operators could optionally add 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.

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

Interventions

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

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.

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:

• 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.

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

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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 8, 2025
• First Posted: December 19, 2025
• Study Start: November 6, 2024
• Primary Completion: May 29, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2-year sharing window post-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. 2. Access Process - Submit application (proposal, CV, IRB approval, signed DUA) to the corresponding author via designated email.

Locations

CN (1)