Atrial Fibrillation, Left Atrial Appendage Occlusion
Conditions
Keywords
atrial fibrillation; left atrial appendage occlusion
Brief summary
The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.
Detailed description
Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.
Interventions
DEVICEleft atrial appendage occlusion devices
All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital; * Adult patients (\>18 years old).
Exclusion criteria
* Patients with rheumatic valvular disease; * Patients with sick sinus syndrome; * Patients who had a history of cardiac surgery (i.e., CABG); * patients who had received the catheter radiofrequency ablation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebral events (MACCE) | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years | A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years | Death from cardiovascular causes |
| Ischemic stroke | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years | Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemia in origin, with signs or symptoms lasting\>24h |
| All-cause death | From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years | Death from any cause |
| Heart failure rehospitalization | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years | Rehospitalization for heart failure |
| Pericardial effusion | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years | Pericardial effusion validated by echocardiography |
| Major bleeding | From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years | The incidence of major bleeding as defined by BARC (3-5) |
Countries
China
Contacts
Primary ContactMengmeng Gong, M.D.
Outcome results
None listed