FIH of PFBalloon for PVI

NCT07320976 | Active Not Recruiting

• 1 other identifier: PFBalloon-FIH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the safety and effectiveness of a conformal pulsed field ablation (PFA) balloon catheter for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). It will also explore the durable effectiveness of this novel catheter through post-ablation remapping. The main questions it aims to answer are: Does the conformal PFA balloon catheter achieve absence of periprocedural primary adverse events (primary safety endpoint)? Does the conformal PFA balloon catheter achieve acute PVI (primary effectiveness endpoint) and durable PVI at three months post-ablation (secondary effectiveness endpoint)? This is a first-in-human, single-center trial that employs a novel PFA balloon catheter with a biphasic, bipolar 750 V waveform. The balloon is inflated with a 10:1 saline/contrast mixture, with deployment volume adjusted to form a sphere shape for wide-antral PV ablation or a pear shape for targeted ostial-junction ablation to ensure optimal tissue contact. Participants will: Undergo PVI using the novel conformal PFA balloon catheter; Be monitored for periprocedural primary adverse events to assess safety; Undergo remapping at three months post-ablation to assess durable PVI; Undergo follow-up visits scheduled for seven-days, 30-days, three-months, six-months, and 12-months post-procedure. Recurrence assessment includes: 1) routine 12-lead ECG examination during each visit and 2) 24-hour or seven-day Holter monitoring at six and 12 months.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal atrial fibrillation; Pulsed field ablation; pulmonary vein isolation; first-in-human

Outcome Measures

Primary Outcomes (2)

• Incidence of Primary Adverse Events Within 3 Months Post-Ablation [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 considered PAEs. Persistent diaphragmatic paralysis/phrenic nerve palsy at 3 months were classified as PAEs.

  Within 3 months post-ablation.

• Acute Procedural Success: Confirmation of Entrance/Exit Block in All Targeted Pulmonary Veins [Primary Effectiveness Endpoint]

  The primary effectiveness endpoint was acute procedural success, defined as confirmation of entrance/exit block in all targeted pulmonary veins.

  Immediately after the ablations

Secondary Outcomes (3)

• Patient-Based Durable Pulmonary Vein Isolation (PVI) Rate at 3-Month Remapping [Secondary Effectiveness Endpoint]

  3 months post the index ablation procedure.

• Vein-Based Durable Pulmonary Vein Isolation Rate at 3-Month Remapping [Secondary Effectiveness Endpoint]

  3 months post the index ablation procedure.

• 1-Year Clinical Efficacy Assessed by Freedom from Atrial Fibrillation (AF) Recurrence [Secondary Effectiveness Endpoint]

  1 year post the index ablation procedure.

Study Arms (1)

PFA for PVI

EXPERIMENTAL

The participates received PVI using a PFBalloon catheter with a novel waveform (Biphasic, Bipolar, 750 V) under general anesthesia. The balloon was inflated with 10:1 saline/contrast mix. Deployment-volume was adjusted to achieve a ball-shape, for performing wide antral catheter ablation (WACA), and a pear-shape, for ablating PV antra, ensuring optimal tissue contact with 8 applications per vein.

Device: PVI with a novel PFA catheter

Interventions

PVI with a novel PFA catheter DEVICE

PVI with a PFBalloon catheter with 8 applications per vein

PFA for PVI

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 18-75 years
• Documented symptomatic paroxysmal atrial fibrillation with episode duration \<7 days
• Refractory or intolerant to at least one Class I or III antiarrhythmic drug

You may not qualify if:

• Atrial fibrillation caused by reversible or non-cardiac factors
• Prior AF ablation or cardiac surgery history
• Anticipated need for extra-pulmonary vein isolation (extra-PVI) ablation
• Persistent atrial fibrillation
• Left atrial diameter \>50 mm
• Left ventricular ejection fraction \<40%
• Presence of an implantable cardiac device (e.g., pacemaker, implantable cardioverter-defibrillator)
• Intracardiac thrombus

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Study Sites (1)

The Third People's Hospital of Chengdu

Chengdu, Sichuan, 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: January 6, 2026
• Study Start: July 10, 2024
• Primary Completion: February 18, 2025
• Study Completion: March 15, 2026
• Last Updated: January 6, 2026

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 to the corresponding author via designated email.

Locations

CN (1)