Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter, which is designed to treat rapid heart rhythm problems like atrial fibrillation (an irregular heartbeat) and supraventricular tachycardia (a fast heartbeat that starts in the upper chambers of the heart). The study aims to see if this device is safe, works well, and is cost-effective for patients who need a procedure called catheter ablation, where small areas of heart tissue causing the abnormal rhythm are treated to restore a normal heartbeat.

Adults between 18 and 75 years old who have been diagnosed with these types of fast heart rhythms and are recommended for catheter ablation may be eligible to participate. Participants will need to agree to the procedure and follow-up visits to check their progress. However, people with certain heart or health conditions—like very large heart chambers, recent strokes, severe infections, or serious liver or kidney problems—will not be able to join the study. This trial is not yet recruiting patients, but it offers hope for a new treatment option that uses tissue temperature measurement to improve the safety and effectiveness of the ablation procedure.

Gender

ALL

Eligibility criteria

• • 1. Inclusion Criteria
• • 1. Patient age between 18 and 75 years old, male or non-pregnant female;
• • 2. Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;
• • 3. Signed informed consent form approved by the ethics committee;
• • 4. Willingness to undergo follow-up and evaluation as required by the protocol.
• 2. Exclusion Criteria Include:
• 1. 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.
• 2. 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.