Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

Shanghai 10th People's Hospital150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Atrial Fibrillation Left Atrial Appendage Occlusion

Interventions

left atrial appendage occlusion devicesDEVICE

All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Major adverse cardiovascular and cerebral events (MACCE)

A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events

Time frame: 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

Secondary Outcomes

All-cause death

Death from any cause

Time frame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years

Cardiovascular death

Death from cardiovascular causes

Time frame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years

Ischemic stroke

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

Time frame: 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

Major bleeding

The incidence of major bleeding as defined by BARC (3-5)

Time frame: 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

Heart failure rehospitalization

Rehospitalization for heart failure

Time frame: 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

Central Contacts

Mengmeng Gong, M.D.

CONTACT

+86-188-0179-0469 zoemodi@outlook.com

Data from ClinicalTrials.gov

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