Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559243
• Other study ID #: LAAC-01
• Status: Recruiting
• Start date: November 12, 2020
• Est. completion date: November 2027

Study information

• Verified date: November 2022
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Chenyang Jiang, Doctor
• Phone: 8613857190051
• Email: panshangming[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.

Description:

Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 579
• Est. completion date: November 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years, male or female;
• Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;
• Indications for left atrial appendage closure;
• Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;

1. HAS-BLED bleeding risk score = 3 points;

2. Not suitable for long-term oral anticoagulant therapy;

3. Poor compliance with oral anticoagulants;

4. CHA2DS2-VASc score ? 2 points;

Exclusion Criteria:

• Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)
• Initial AF, reversible AF with clear cause
• Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus
• ST elevation myocardial infarction, = 3 months
• Grade-IV of Cardiac Function (NYHA)
• Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants
• Pregnant or with plan of pregnancy during the study
• Participation in another drug or medical device clinical trial or study that has not been completed
• Experience new stroke or TI within 30 days or major bleeding events within 14 days
• Contraindication to LAA closure or deemed unsuitable for study participation by the investigator
• Had a definite thromboembolic event

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolic Stroke
• Non-valvular Atrial Fibrillation

Intervention

Diagnostic Test:
• Transthoracic Echocardiography
After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Sichuan Mianyang 404 Hospital	Mianyang	Sichuan
China	Shanghai Songjiang District Central Hospital	Shanghai	Shanghai
China	The first Affiliated Hospital of WMU	Wenzhou	Zhejiang
China	The Second Affiliated Hospital and Yuying Children's Hospital of WMU	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation	Ischemic stroke, systemic embolism, and cardiac death events	12 months
Primary	Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of = 2 units of red blood cells) at 12 months after operation	Bleeding events	12 months
Secondary	Surgical success rate	Surgical success	24 months
Secondary	Success rate of LAA closure at 3 months after operation	Successful LAA closure was defined as a residual shunt = 3 mm by TEE or ICE after implantation of the LAA occluder.	3 months
Secondary	The composite endpoint of new ischemic stroke, systemic embolism and cardiac death at 7 months after operation or before discharge and at 1, 3, 6 and 24 months after operation	Ischemic stroke, systemic embolism, and cardiac death events	24 months
Secondary	(4)Perioperative (7 days after operation or before discharge) surgery-related complications	7 days after operation or pre-discharge procedure-related complications include but are not limited to stroke (ischemic and hemorrhagic stroke), systemic embolism, allergic reaction, gas embolism, pericardial effusion/cardiac tamponade requiring intervention, occluder detachment, occluder thrombosis (DRT), minor bleeding events (including but not limited to puncture site hematoma, non-major bleeding events), infection, arrhythmia, damage to blood vessels or organs on the implantation path and adjacent organs	7 days
Secondary	Procedure-related complications during follow-up	Follow-up at 1, 3, 6, 12 and 24 months after operation for procedure-related complications, including all-cause death, stroke (ischemic and hemorrhagic stroke), cardiac perforation, pericardial effusion/cardiac tamponade requiring intervention, major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of = 2 units of red blood cells), occluder thrombosis (DRT), infection, systemic embolism, allergic reaction, arrhythmia, and other serious cardiovascular events requiring intervention or surgical treatment	24 months
Secondary	Occluder defects during operation and in the 3rd month after operation	Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc	3 months
Secondary	Incidence rate of severe adverse events within 24 months after operation	including but not limited to all-cause death, events requiring hospitalization or prolongation of hospitalization, severe endocarditis requiring surgery, pericarditis, cardiac perforation, valvular injury, vascular or gas embolism events, occluder detachment/displacement, occluder fracture, occluder thrombosis (DRT), stroke events	24 months