NCT07720557

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Nov 2028

Study Start

First participant enrolled

July 10, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

July 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

July 19, 2026

Last Update Submit

July 19, 2026

Conditions

Atrial Fibrillation (AF)Paroxysmal AFDrug Refractory Paroxysmal Atrial FibrillationAtrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • The success rate within 12 months after operation treatment without AADs

    Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure

    12 months

Secondary Outcomes (2)

  • Acute procedural success

    after a 20 min observation period following the last ablation

  • Primary safety endpoint

    Up to 7 days post ablation procedure

Study Arms (1)

PulseMagic™ TrueForce™ Ablation catheter

EXPERIMENTAL

A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.

Device: PFA Ablation catheter

Interventions

PFA Ablation catheterDEVICE

Deliver PF energy using the PulseMagic™ PFA system

PulseMagic™ TrueForce™ Ablation catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Yao

CONTACT

010-88392405ianyao@263.net.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 22, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

July 22, 2026

Record last verified: 2026-06

Locations

CN(1)