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

NCT ID: NCT07036068

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-12-31

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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-centre, post-marketing study

This study aims to evaluate the safety and efficacy of using a domestically produced cardiac cryoablation system to treat paroxysmal atrial fibrillation.

Group Type: EXPERIMENTAL

IceMagic™ CryoAblation Catheter

Intervention Type: DEVICE

IceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.

Interventions

IceMagic™ CryoAblation Catheter

IceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Gao Henggan

Cui Kaijun

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Kaijun K Cui, PhD

Role: CONTACT

hxjj@cd120.com

028-60660000

Facility Contacts

Kaijun K Cui, PhD

Role: primary

hxjj@cd120.com

028-60660000

Other Identifiers

West China Hospital（Sichuan）

Identifier Type: -

Identifier Source: org_study_id