Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai
- Conditions
- Left Atrial Appendage OcclusionAtrial Fibrillation
- Interventions
- Device: left atrial appendage occlusion devices
- Registration Number
- NCT03987945
- Lead Sponsor
- Shanghai 10th People's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Left atrial appendage occlusion left atrial appendage occlusion devices Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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)
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
Trial Locations
- Locations (1)
Department of Cardiology, Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China