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

MicroPort

Status: Not yet enrolling

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Treatments: Device: IceMagic™ CryoAblation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT07036068

West China Hospital（Sichuan）

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single-centre, post-marketing study

Experimental group

Description:

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

Treatment:

Device: IceMagic™ CryoAblation Catheter