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Not yet recruiting NCT07720557

PulseMagic™ TrueForce™ PAF NMPA Study

No phase Interventional Atrial Fibrillation (AF) Paroxysmal AF Drug Refractory Paroxysmal Atrial Fibrillation Atrial Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PFA Ablation catheter.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)

Overview

This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Detailed description

This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.

Interventions

  • Device PFA Ablation catheter
    Deliver PF energy using the PulseMagic™ PFA system

Primary outcome measures

  • The success rate within 12 months after operation treatment without AADs [Time frame: 12 months]
Secondary outcome measures (2)
  • Acute procedural success [Time frame: after a 20 min observation period following the last ablation]
  • Primary safety endpoint [Time frame: Up to 7 days post ablation procedure]

Eligibility criteria

Inclusion criteria

  • Aged ≥ 18 years old.
  • Clinically diagnosed with symptomatic paroxysmal atrial fibrillation.
  • Atrial fibrillation documented by surface electrocardiogram (ECG), or ambulatory electrocardiogram (including single-lead ECG recorder).
  • Poor response or intolerance to at least one Class I or Class III antiarrhythmic drug.
  • Fully informed of the treatment regimen, voluntarily signed the informed consent form, and agreed to undergo all examinations, procedures and follow-up visits specified in the study protocol.

Exclusion criteria

  • Patients with a history of atrial fibrillation ablation.
  • Left atrial thrombus.
  • Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%.
  • Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.).
  • Women of childbearing potential who cannot use effective contraception throughout the 12-month study period after enrollment.
  • Atrial fibrillation caused by hyperthyroidism or other transient factors.
  • Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma.
  • Patients with confirmed cerebrovascular diseases within the past 6 months (including cerebral hemorrhage, stroke and transient ischaemic attack).
  • Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision).
  • Patients deemed ineligible for this trial by the investigator for any other reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sc — Beijing

Identifiers

NCT: NCT07720557 · 775137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗