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

NCT05911685 | Unknown

• 1 other identifier: LAA01
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Device success rate

  immediately after the procedure

• Ischemic stroke rate

  12 months after the procedure

• Major adverse events rate

  7 days after procedure

Study Arms (1)

Left atrial appendage occlusion

EXPERIMENTAL

Device: SeaLA™ left atrial appendage occluder

Interventions

SeaLA™ left atrial appendage occluder DEVICE

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.

Left atrial appendage occlusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• History of stroke or TIA(transient ischemic attack) within 30 days;
• Thrombocytopenia (platelets≤ 100.000 pcs/mcL);
• Active endocarditis, sepsis;
• Heart tumor or other malignant tumor, life expectancy \< 1 year;
• 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);
• 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;
• The subject is subordinate to the sponsor or clinical trial institution or investigator;

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (1)

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Shengyang, China

Location

Related Publications (1)

• 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.

  PMID: 38841867 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 22, 2023
• Study Start: March 26, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)