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NCT06014996: InsightPFA

InsightPFA Trial of the LotosPFA Catheter

Completed NA Last updated 17 August 2025
What this trial tests

NA trial testing Pulsed Field Ablation (PFA) Therapy in Arrhythmias, Cardiac in 292 participants. Completed in 3 July 2025.

Timeline
4 September 2023
Primary endpoint
9 June 2025
3 July 2025

Quick facts

Lead sponsorInsight Medtech Co., Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment292
Start date4 September 2023
Primary completion9 June 2025
Estimated completion3 July 2025
Sites10 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Insight Medtech Co., Ltd.

Who can join

Adults 18 to 75, any sex, with Arrhythmias, Cardiac or Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Intraprocedural activated clotting time and heparin dosage in pulsed field ablation of paroxysmal atrial fibrillation.
    Ma C, Xiao X, Chen Q, Li W, et al · · 2025 · cited 2× · PMID 40066349 · DOI 10.3389/fcvm.2025.1501716
  2. Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial.
    Lin W, Chu H, Wang C, Chang D, et al · · 2025 · cited 1× · PMID 41338842 · DOI 10.1016/j.jacc.2025.09.1593
  3. Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation.
    Lin W, Pu S, Chu H, Chang D, et al · · 2025 · cited 1× · PMID 39853845 · DOI 10.1111/jce.16573

Verify or expand the search:

Other trials of Pulsed Field Ablation (PFA) Therapy

Trials testing the same drug.

Other recruiting trials for Arrhythmias, Cardiac

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06014996.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing