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This study adapted a prospective, multicenter single-group objective performance criteria design. A total of 163 patients with non-valvular atrial fibrillation were enrolled in the clinical trial,follow up were scheduled in 7 days, 45 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5years after procedure.
This study adapted a prospective, multicenter single-group objective performance criteria design。A total of 163 patients with non-valvular atrial fibrillation were enrolled in the clinical trial, the patients signed the informed consent form and met the inclusion and exclusion criteria, the subjects were implanted with the SeaLA™ LAA (left atrial appendage) occlusion, and TTE(transthoracic echocardiography) examination was performed 7 days after procedure or before discharge (whichever comes first), TEE(transesophageal echocardiography) examination were performed 45 days and 6 months after procedure, and TTE examination at 12 months. In the 2nd, 3rd, 4th, and 5th years of telephone follow-up subjects, the main adverse event data were collected and analyzed, and the long-term safety and efficacy of the left atrial appendage closure device product after implantation were evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left atrial appendage occlusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeaLA™ left atrial appendage occluder | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left atrial appendage closure rate | After the closure device is implanted, it is confirmed by ultrasound that no forward or reverse blood flow passes through the closure device, and the residual forward or reverse blood flow at the edge of the closure device is ≤ 3mm | 6 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | smooth delivery of left atrial appendage occluder to left atrial appendage, successful release of left atrial appendage occlusion, smooth withdrawal of delivery system | immediately after the procedure |
| Ischemic stroke rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of the Northern Theater of the Chinese People's Liberation Army | Shengyang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38841867 | Derived | Wang Z, Chu H, Chen X, Tao L, Yuan Y, Ru L, Wang J, Fan Y, Hu H, Wang C, Chen M, Huang W, Zhou D, Liu X, Liang M, Liu J, Han Y. Percutaneous left atrial appendage closure with SeaLA device in non-valvular atrial fibrillation. Catheter Cardiovasc Interv. 2024 Dec;104(7):1491-1498. doi: 10.1002/ccd.31056. Epub 2024 Jun 6. |
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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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Ischemic stroke refers to the loss of nerve function caused by transient ischemic attack, cerebral thrombosis or cerebral embolism caused by the brain itself and/or systemic blood circulation disorders leading to cerebral blood supply disorders. Ischemic stroke is defined as a modified Rankin score (mRS) ≥2 90 days after stroke onset. The scale runs from 0 to 5, running from perfect health without symptoms to death, higher scores mean a worse outcome, 0 means no symptoms, 5 means dead.
| 12 months after the procedure |
| Major adverse events rate | Unexplained death or any device- or procedure-related complications, including but not limited to: death, severe cardiac tamponade requiring pericardiocentesis or surgery, instrument embolism, surgery-related stroke. | 7 days after procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |