Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai (LAAO-SH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Left Atrial Appendage Occlusion
• Intervention / Treatment: Device: left atrial appendage occlusion devices

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Cardiology, Shanghai Tenth People's Hospital
      • Contact: Mengmeng Gong, M.D.; Phone Number: +86-188-0179-0469; Email: zoemodi@outlook.com
      • Principal Investigator: Yawei Xu, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with NVAF who are referred for LAAO procedure.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Left atrial appendage occlusion; Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Yawei Xu, M.D., Ph.D., Department of Cardiology, Shanghai Tenth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation; left atrial appendage occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LAAO-SH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No