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This study is expected to include 166 subjects and Conducted at 11 research centersï¼›The expected 12 month treatment success rate of using research instruments is 65%.
Principle evaluation indexes:
Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Secondary evaluation indexes:
Safety evaluation indexes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Each subject underwent pulse ablation catheter ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse ablation catheter | Device | Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate success rate of surgery | Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100% | After surgery 20 minutes later |
| Treatment success rate | Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100% | Between 3 months and 12 months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| numer of cases of the the occurrence of hospitalization or emergency treatment | The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery; | Between 0 months and 12 months after ablation |
| Device performance evaluation |
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Inclusion Criteria:
Subjects must meet all of the following conditions to be enrolled:
Exclusion Criteria:
Subjects were excluded if they met one of the following conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital) | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41636062 | Derived | Xie S, Lai H, Jia F, Zhang Z, Wang Y, Yin Y, Chen Q, Huang H, Liu Q, He J, Yang P, Wang J. High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial. Circ Arrhythm Electrophysiol. 2026 Feb;19(2):e014236. doi: 10.1161/CIRCEP.125.014236. Epub 2026 Feb 4. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Device defects of the clinical trial equipment |
| surgery period |
| D013568 |
| Pathological Conditions, Signs and Symptoms |