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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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. Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation?
2. Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping?

Study Design and Intervention

Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions.

Participant Follow-up Protocol

Enrolled participants will complete the following assessments:

1. Index Procedure: PVI and linear ablation with the PFApple PFA catheter.
2. Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability.
3. 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.

Eligibility

Primary outcome measure(s)

• The primary safety endpoint — 3 months post-ablation
  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.
• The primary efficacy endpoint — Immediately post-ablation
  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).

Trial sites (1)

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

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