Clinical trial NCT05911685: Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder
Official title: A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder in Patients With Nonvalvular Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Hangzhou Dinova EP Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with nonvalvular paroxysmal, persistent or permanent atrial fibrillation;
2. Subject is not suitable for long-term treatment with anticoagulant;
3. CHA2DS2-VASC score（Atrial fibrillation stroke risk score） ≥ 2;
4. Subjects are suitable for dual antiplatelet therapy for 3 months and complete follow-up;

Exclusion Criteria:

1. Patients with atrial fibrillation caused by rheumatic heart valve disease, degenerative heart valve disease, or congenital heart valve disease;
2. Patients after heart transplantation;
3. Unstable angina or recent myocardial infarction \< 3 months;
4. Cardiac function IV (NYHA grade);
5. Subject requires atrial fibrillation catheter ablation surgery within 30 days of LAA occlusion device implantation;
6. Excludes the case of atrial fibrillation catheter ablation and LAA closure in the same surgery (if atrial fibrillation catheter ablation and LAA closure are operated on the same operation, it is recommended to have catheter ablation before closure);
7. Subject has an electrical cardioversion plan within 30 days of LAA occlusion device implantation;
8. After mechanical prosthetic valve implantation;
9. History of stroke or TIA(transient ischemic attack) within 30 days;
10. Thrombocytopenia (platelets≤ 100.000 pcs/mcL);
11. Active endocarditis, sepsis;
12. Heart tumor or other malignant tumor, life expectancy \< 1 year;
13. subjects who are pregnant, lactating or planning to become pregnant during clinical trials (must undergo a pregnancy test before surgery, except for women of non-childbearing age);
14. are currently participating in clinical trials of other drugs or medical devices and have not completed the primary endpoint of the study, which may cause confusion in the results of this study or may affect subjects' compliance with this study follow-up;
15. The subject is subordinate to the sponsor or clinical trial institution or investigator;
16. The investigator judged that the subject's compliance was poor and could not complete the clinical trial requirements;
17. Allergy to nitinol or contrast media;
18. There is a complex movable/ruptured/\> 4mm atherosclerotic plaque at the ascending aorta/aortic arch;
19. Patients with symptomatic carotid artery stenosis (such as carotid artery stenosis greater than 50%);

Primary outcomes:
measure: Left atrial appendage closure rate
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Device success rate
timeFrame: immediately after the procedure
measure: Ischemic stroke rate
timeFrame: 12 months after the procedure
measure: Major adverse events rate
timeFrame: 7 days after procedure
Other outcomes:
Locations:
city: Shengyang
country: China
facility: General Hospital of the Northern Theater of the Chinese People's Liberation Army
Study officials:
References: