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

NCT07036068 | Not Yet Recruiting

• 1 other identifier: West China Hospital（Sichuan）
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

PFA; PeAF; PFA/RF

Outcome Measures

Primary Outcomes (1)

• Three-month follow-up success rate 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.

  Three months after surgery

Secondary Outcomes (1)

• Immediate ablation success rate

  On the 1 day of the surgery

Study Arms (1)

Single-centre, post-marketing study

EXPERIMENTAL

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

Device: IceMagic™ CryoAblation Catheter

Interventions

IceMagic™ CryoAblation Catheter 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.

Single-centre, post-marketing study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age between 18 and 80 years old, male or non-pregnant female.
• Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.
• 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.

You may not qualify if:

• Patients who have undergone atrial fibrillation ablation surgery
• Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
• Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
• Left atrial thrombus
• Patients who have undergone atrial septal defect repair surgery or atrial myxoma
• Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
• 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)
• Patients with acute or severe systemic infection
• Patients with severe liver or kidney disease
• Patients with a significant tendency to bleed or haematological disorders
• Patients with malignant tumours or end-stage diseases
• Patients deemed ineligible for this trial by the investigator

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kaijun K Cui, PhD

CONTACT

028-60660000; hxjj@cd120.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cui Kaijun

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: August 31, 2025
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)