A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical study is looking at a new treatment for paroxysmal atrial fibrillation (PAF), which is a type of irregular heartbeat that comes and goes. The study will test a special freezing technique, called balloon cryoablation, along with some new tools that help the doctor map the heart and guide the treatment. The goal is to see if this method is safe and effective in treating PAF.

Adults between 18 and 80 years old who have been diagnosed with paroxysmal atrial fibrillation and need this type of treatment may be eligible to join. To participate, you’ll need to understand the treatment plan and agree to follow the study’s schedule for tests, the procedure, and follow-up visits. The study will not include people who have had previous heart ablation surgery, have certain heart or health conditions, or who are unable to use birth control if they could become pregnant. If you join, you can expect to have the balloon freezing procedure to help restore a regular heartbeat, along with careful monitoring before and after the treatment to make sure it’s working well and safe for you.

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 cryoablation 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. Patients who have undergone atrial fibrillation ablation surgery
• • 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. Patients who have undergone atrial septal defect repair surgery or atrial myxoma
• • 6. Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
• • 7. 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)
• • 8. Patients with acute or severe systemic infection
• • 9. Patients with severe liver or kidney disease
• • 10. Patients with a significant tendency to bleed or haematological disorders
• • 11. Patients with malignant tumours or end-stage diseases
• • 12. Patients deemed ineligible for this trial by the investigator