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FIH Study of PFLotus in Persistent Atrial Fibrillation

NCT07301190 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-24

No results posted yet for this study

Summary

Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF).

The main questions it aims to answer are:

1. Is there an absence of serious procedure or device-related adverse events within 7 days?
2. Can the catheter achieve durable lesions?

This trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical).

Participants will:

1. Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia;
2. Undergo remapping within 3-month post the index ablation to assess the durability of the lesions;
3. Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Pulse field ablation with the PFLotus catheter

PVI was performed in all patients. Additional linear ablation strategies Including the left atrial posterior wall (LAPW), mitral isthmus (MI), or cavotricuspid isthmus (CTI), were performed at the operator's discretion.

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
2025-06-11
Primary Completion
2026-03-31
Completion
2027-04-15

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 NCT07301190 on ClinicalTrials.gov