Atrial Fibrillation (AF)PFATrueForceNCT07720557
PulseMagic™ TrueForce™ PAF NMPA Study
A study testing PFA Ablation catheter in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation
- What is being tested?
- PFA Ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality
About this study
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)
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).
Read the 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.
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Being tested
- PFA Ablation catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFA Ablation catheterDevice
Deliver PF energy using the PulseMagic™ PFA system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PFA Ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Acute procedural success
Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
Measured: after a 20 min observation period following the last ablation
Primary safety endpoint
The incidence of primary adverse events refers to the rate of early-onset adverse events occurring within 7 days after ablation, including: vagal reflex complicated with severe bradycardia, acute coronary injury/occlusion, acute kidney injury, myocardial infarction, phrenic nerve injury/paralysis, left atrial-esophageal fistula, transient ischaemic attack, stroke/cerebrovascular accident/thromboembolism, pericarditis requiring intervention, cardiac tamponade/perforation, pneumothorax, severe vascular access complications and death.
Measured: Up to 7 days post ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720557
- Sponsor's protocol ID
- 775137
- Acronym
- PFATrueForce
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In accordance with the company's regulatory provisions, subject information must be maintained in strict confidence.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07720557
- Acronym / sponsor ID
- PFATrueForce / 775137
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PulseMagic™ TrueForce™ Ablation catheter | Experimental | Device: PFA Ablation catheterA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFA Ablation catheterDeliver PF energy using the PulseMagic™ PFA system | Device | PulseMagic™ TrueForce™ Ablation catheter |
Primary outcome
The success rate within 12 months after operation treatment without AADs
Time frame: 12 months
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided. In accordance with the company's regulatory provisions, subject information must be maintained in strict confidence.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFA Ablation catheter in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yao (010-88392405, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate within 12 months after operation treatment without AADs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.