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. (part of LifeTech Scientific Corporation) · 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).
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's planned enrollment of 579 is above the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with non-valvular atrial fibrillation and previous AF-related embolic events
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Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Nov 2020 (actual). Primary completion is estimated for Nov 2025, 60 months after the start.
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