Clinical trial NCT03987945: Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai
Official title: Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Left Atrial Appendage Occlusion
Keywords: atrial fibrillation; left atrial appendage occlusion
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with NVAF who are referred for LAAO procedure.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular and cerebral events (MACCE)
timeFrame: 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:
measure: All-cause death
timeFrame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
measure: Cardiovascular death
timeFrame: From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
measure: Ischemic stroke
timeFrame: 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
measure: Major bleeding
timeFrame: 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
measure: Heart failure rehospitalization
timeFrame: 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
measure: Pericardial effusion
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital
name: Yawei Xu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: