NCT05911685

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	SeaLA™ left atrial appendage occluder	1. Guided by esophageal ultrasound (TEE) and angiography, the diameter of the left atrial appendage anchoring zone and the longest depth of the left atrial appendage were measured to determine the appropriate size of the left atrial appendage occluder. 2. Maintain Activated Clotting Time (ACT) greater than 250 seconds after atrial septal puncture to the completion of the entire procedure. 3. Before the plugging device is released, confirm whether there is a residual peri-device leak, and if there is a residual peri-device leak, consider retracting the occluder to reposition the release or retract the occluder to choose a larger size occluder to re-occlusion. If ultrasound confirms residual peri-device leak greater than 5 mm, do not release and implant the left atrial appendage occluder. 4. Before and after release, confirm the position and stability of the occluder under ultrasound (TEE), and confirm that the occluder completely occludes the left atrial appendage.

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-01-21
• Completion: 2025-01-21
• First posted: 2023-06-22
• Last updated: 2023-06-27

Locations

1 site across 1 country: China