FIH of PFBalloon for PVI

Condition(s) studied

Investigational drug(s) / intervention(s)

PVI with a novel PFA catheter: PVI with a PFBalloon catheter with 8 applications per vein

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.

Eligibility

Primary outcome measure(s)

• Incidence of Primary Adverse Events Within 3 Months Post-Ablation [Primary Safety Endpoint] — Within 3 months post-ablation.
  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.
• Acute Procedural Success: Confirmation of Entrance/Exit Block in All Targeted Pulmonary Veins [Primary Effectiveness Endpoint] — Immediately after the ablations
  The primary effectiveness endpoint was acute procedural success, defined as confirmation of entrance/exit block in all targeted pulmonary veins.

Trial sites (1)

More The Third People's Hospital of Chengdu trials in China

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