Rapid ArrhythmiaNCT07032948
Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
A study testing FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System in people with Rapid Arrhythmia and Atrial Fibrillation (AF), run by Shanghai MicroPort EP MedTech Co., Ltd..
Trial summary
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- What is being tested?
- FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2025to 31 Aug 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria
- Patient age between 18 and 75 years old, male or non-pregnant female;
- Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;
- Signed informed consent form approved by the ethics committee;
- Willingness to undergo follow-up and evaluation as required by the protocol.
- Exclusion Criteria Include:
- Exclusion criteria for atrial fibrillation patients: Patients should not participate in this study if any of the following conditions apply:
- Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;
- Left atrial thrombus;
- History of atrial septal repair or atrial myxoma;
- History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
- Cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
- Acute or severe systemic infection;
- Severe liver or kidney disease;
- Significant bleeding tendency or haematological disorders;
- Patients with other conditions deemed inappropriate for participation in this trial by the investigators.
- Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:
Patients should not participate in this study if any of the following conditions apply:
- Left atrial size ≥50 mm and left ventricular ejection fraction ≤40%;
- History of atrial septal defect repair or atrial myxoma;
- Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
- Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
- Patients with acute or severe systemic infection;
- Patients with severe liver or kidney disease;
- Patients with a significant tendency to bleed or haematological disorders;
- Patients with other conditions deemed by the investigator to be unsuitable for participation in this trial.
About this study
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
Read the detailed description
This project will conduct a clinical demonstration application study involving 300 cases, with the aim of evaluating the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Conditions
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- Being tested
- FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation SystemDevice
All patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation） | Experimental | Not described Receives: Device: FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
major evaluation indicators--Efficacy indicators
Immediate success rate of the investigational device in treating rapid arrhythmias;
Measured: On the day of the surgery
Major evaluation indicators--Monitoring methods
Radiofrequency ablation treatment of rapid arrhythmias (such as supraventricular tachycardia and atrial fibrillation) using the trial device, with immediate ablation success determined based on the operator's professional experience combined with real-time intracardiac electrocardiogram display, followed by statistical analysis;
Measured: On the day of the surgery
Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices
Statistics on the incidence of adverse events related to surgical instruments during the perioperative period
Measured: perioperative period
Secondary outcomes (2)
Changes in the surface temperature of the ablated tissue
extract multiple surface temperature data through tissue temperature measurement catheter microelectrodes and perform statistical analysis;
Measured: During surgery
Changes in ablation point impedance
evaluate secondary indicators of tissue temperature measurement catheters, observe the impedance display of the radiofrequency ablation device, and record whether the impedance decreases during ablation
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid ArrhythmiaStudies 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
- 300 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
- NCT07032948
- Sponsor's protocol ID
- Shanghai MicroPort EP MedTech
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
- ClinicalTrials.gov ID
- NCT07032948
- Acronym / sponsor ID
- Shanghai MicroPort EP MedTech
- Conditions
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Jun 2025 (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 project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
Detailed description
This project will conduct a clinical demonstration application study involving 300 cases, with the aim of evaluating the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation） | Experimental | Device: FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation SystemAll patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia. | Device | Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation） |
Primary outcome
major evaluation indicators--Efficacy indicators
Time frame: On the day of the surgery
Immediate success rate of the investigational device in treating rapid arrhythmias;
Major evaluation indicators--Monitoring methods
Time frame: On the day of the surgery
Radiofrequency ablation treatment of rapid arrhythmias (such as supraventricular tachycardia and atrial fibrillation) using the trial device, with immediate ablation success determined based on the operator's professional experience combined with real-time intracardiac electrocardiogram display, followed by statistical analysis;
Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices
Time frame: perioperative period
Statistics on the incidence of adverse events related to surgical instruments during the perioperative period
2 secondary outcomes
Changes in the surface temperature of the ablated tissue
Time frame: During surgery
Changes in ablation point impedance
Time frame: During surgery
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 24 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System in people with Rapid Arrhythmia and Atrial Fibrillation (AF), run by Shanghai MicroPort EP MedTech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major evaluation indicators--Efficacy indicators (time frame: On the day of the surgery). The study lists 3 primary outcomes in all. 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 24 Jun 2025.