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

NCT07294742 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-19

No results posted yet for this 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.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

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.

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
2024-11-06
Primary Completion
2025-05-29
Completion
2026-06-15

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 NCT07294742 on ClinicalTrials.gov