NCT07720557Not yet recruiting
PulseMagic™ TrueForce™ PAF NMPA Study
A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Jul 2026
- Start date
- 10 Jul 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07720557
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 10 Jul 2026 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma.
Other illness
- Patients with a history of atrial fibrillation ablation.
- Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.).
- 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).
Lab values
- Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%.
Other
- Left atrial thrombus.
- 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 deemed ineligible for this trial by the investigator for any other reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.