A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat paroxysmal atrial fibrillation (PAF), which is a type of irregular heartbeat that comes and goes. The study is testing a special heart mapping system made locally that uses pressure monitoring and a star-shaped marking technique to see if it is safe and effective when combined with a common treatment called catheter radiofrequency ablation. This procedure uses heat to fix the heart’s electrical signals and help restore a normal rhythm.

People who might join this study are adults between 18 and 80 years old who have been diagnosed with paroxysmal atrial fibrillation and are scheduled for the ablation procedure. Participants need to understand the treatment and agree to take part by signing a consent form. The study is not yet open for recruiting, and certain health conditions, like a very large heart chamber, recent strokes, or serious infections, may prevent someone from joining. If you take part, you can expect to have detailed heart examinations, the ablation procedure using the new mapping system, and follow-up visits to check how well the treatment works and ensure your safety. This trial aims to improve treatment options for people with this common heart rhythm problem.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient age between 18 and 80 years old, male or non-pregnant female.
• • 2. Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery.
• • 3. Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
• Exclusion Criteria:
• • 1. Post-ablation for atrial fibrillation
• • 2. Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
• • 3. Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
• • 4. Left atrial thrombus
• • 5. History of atrial septal defect repair or atrial myxoma
• • 6. History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
• • 7. History of 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)
• • 8. Patients with acute or severe systemic infection
• • 9. Patients with severe liver or kidney disease
• • 10. Patients with significant bleeding tendencies or haematological disorders
• • 11. Patients with malignant tumours or end-stage diseases
• • 12. Patients deemed ineligible for this trial by the investigator