NCT07032948Not yet recruiting
Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 31 Aug 2025
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07032948
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 31 Aug 2025 to the primary completion date, 31 Aug 2025
- No sites listed in no 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.
Criteria the registry did not label
- 1\. 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.
- 2\. 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.