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

Not Applicable

Not yet recruiting

• Conditions: Paroxysmal Atrial Fibrillation (PAF)

• Registration Number: NCT07036068
• Lead Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Brief Summary

To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-24
• Study First Posted: 2025-06-25
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-31
• Primary Completion: 2025-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Three-month follow-up success rate after surgery	Three months after surgery	Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period post-surgery (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.

Secondary Outcome Measures

Name	Time	Method
Immediate ablation success rate	On the 1 day of the surgery	This refers to the proportion of subjects who achieved electrical isolation after surgery among the total number of patients enrolled in the study. The verification method involves waiting for 20 minutes after successful pulmonary vein electrical isolation and then reconfirming pulmonary vein conduction block.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China