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

Atrial Fibrillation Clinical Trial

— LAAO-SH  

Official title:

Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987945
• Other study ID #: LAAO-SH
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Shanghai 10th People's Hospital
• Contact: Mengmeng Gong, M.D.
• Phone: +86-188-0179-0469
• Email: zoemodi[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Occlusion

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular and cerebral events (MACCE)	A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events	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	All-cause death	Death from any cause	From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Secondary	Cardiovascular death	Death from cardiovascular causes	From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years
Secondary	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	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	Major bleeding	The incidence of major bleeding as defined by BARC (3-5)	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	Heart failure rehospitalization	Rehospitalization for heart failure	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	Pericardial effusion	Pericardial effusion validated by echocardiography	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