An observational study in Non-valvular Atrial Fibrillation and Embolic Stroke, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. · Observational
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.
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).
Patients with non-valvular atrial fibrillation and previous AF-related embolic events
Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
Exclusion Criteria:
After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
Also known as: Transesophageal Echocardiography
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Ischemic stroke, systemic embolism, and cardiac death events
Time frame: 12 months
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
Time frame: 12 months
Surgical success rate
Surgical success
Time frame: 24 months
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.
Time frame: 3 months
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
Time frame: 24 months
(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
Time frame: 7 days
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
Time frame: 24 months
Occluder defects during operation and in the 3rd month after operation
Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc
Time frame: 3 months
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
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lifetech Scientific (Shenzhen) Co., Ltd.