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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IceMagicâ„¢ CryoAblation Catheter | Device | IceMagicâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate ablation success rate | 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. | On the 1 day of the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaijun K Cui, PhD | Contact | 028-60660000 | hxjj@cd120.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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