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FIH of PFBalloon for PVI

NCT07320976 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-06

No results posted yet for this study

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

Interventions

DEVICE

PVI with a novel PFA catheter

PVI with a PFBalloon catheter with 8 applications per vein

Sponsors & Collaborators

  • The Third People's Hospital of Chengdu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-02-18
Completion
2026-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07320976 on ClinicalTrials.gov