Nonvalvular atrial fibrillation
Conditions
Interventions
Observation group:NA
Sponsors
The People's Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age>= 18 years, regardless of gender; 2.Prospective enrollment: Patients who meet the indications for percutaneous left atrial appendage closure (LAAC) and choose to undergo the procedure with the LAmbre™ Left Atrial Appendage Occluder System; 3.Retrospective enrollment: Patients with non-valvular atrial fibrillation (NVAF) who met the indications for percutaneous LAAC and have previously undergone the procedure (isolated implantation) with the LAmbre™ Left Atrial Appendage Occluder System; 4.For retrospectively enrolled patients, at the time of enrollment, there must be one post-implant imaging assessment result (via TEE or cardiac CTA) available for the occlusion status within 1 year after the LAmbre™ device implantation; 5.Patients who voluntarily agree to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with bleeding disorders or a tendency for major bleeding; 2.Patients who meet any contraindication for the implantation of the LAmbre™ Left Atrial Appendage Occluder; 3.Pregnancy, or pregnancy detected at screening, or planning to become pregnant during the study period, or lactating women; 4.Participation in another clinical study within 30 days prior to enrollment that may interfere with this study's outcomes and has not reached its primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Major Clinical Events Within 60 Months Post-Procedure: Major clinical events represent a composite endpoint, encompassing: All new-onset strokes (including ischemic and hemorrhagic); Cardiac death; Death of undetermined cause; Systemic embolism. Definition of Systemic Embolism: Embolic events occurring in vascular territories other than the brain, such as: Myocardial infarction Pulmonary embolism Renal infarction Splenic infarction Limb ischemia Mesenteric ischemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Device Implantation-Related Complications During the Perioperative Period *(Defined as intraoperatively through post-procedure day 7, or discharge day/the day prior to discharge if hospitalization is <7 days)* Complications include but are not limited to: Stroke (hemorrhagic/ischemic) Device-related thrombosis (DRT) Systemic embolism Cardiac tamponade Device embolization Device fracture Device damage Injury to implant access vessels and organs, or adjacent anatomical struct;Incidence of Pericardial Effusion (Requiring and Not Requiring Intervention) at 12, 24, 36, 48, and 60 Months Post-Procedure Definition of Pericardial Effusion Requiring Intervention: Pericardial effusion necessitating pericardiocentesis and/or surgical intervention;Stroke and Systemic Embolism at 12, 24, 36, 48, and 60 Months Post-Procedure *Calculated as the number of events per 100 patient-years of follow-up; | — |
Countries
China
Contacts
Public ContactHe Huang
The People's Hospital of Wuhan University
Outcome results
None listed