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 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai MicroPort EP MedTech Co., Ltd

Phase

Not applicable

Started

2025-08-31

Last updated

2025-06-27

Condition(s) studied

Paroxysmal Atrial Fibrillation (PAF)

Investigational drug(s) / intervention(s)

IceMagic™ CryoAblation Catheter

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
West China Hospital of Sichuan University	Chengdu	Sichuan

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Other trials for the same condition

Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Starting soon

Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study) Starting soon

Sphere-9 PAF China Study Starting soon

Grid eXplore Mapping Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07036068 on ClinicalTrials.gov ↗ ← All trials in China