UnknownNot Applicable

Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder

China163 participantsStarted 2019-03-26

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Patients with atrial fibrillation caused by rheumatic heart valve disease, degenerative heart valve disease, or congenital heart valve disease;
✕. Patients after heart transplantation;
✕. Unstable angina or recent myocardial infarction \< 3 months;
✕. Cardiac function IV (NYHA grade);
✕. Subject requires atrial fibrillation catheter ablation surgery within 30 days of LAA occlusion device implantation;
✕. 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);
✕. Subject has an electrical cardioversion plan within 30 days of LAA occlusion device implantation;
✕. After mechanical prosthetic valve implantation;

What they're measuring

Left atrial appendage closure rate

Timeframe: 6 months after procedure

Trial details

NCT IDNCT05911685

SponsorHangzhou Dinova EP Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-21

View on ClinicalTrials.gov More Atrial Fibrillation trials