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Clinical Trials/NCT03987945
NCT03987945
Unknown
Not Applicable

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

Shanghai 10th People's Hospital1 site in 1 country150 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Shanghai 10th People's Hospital
Enrollment
150
Locations
1
Primary Endpoint
Major adverse cardiovascular and cerebral events (MACCE)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
June 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ya-Wei Xu

Chief Physician

Shanghai 10th 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.

Outcomes

Primary Outcomes

Major adverse cardiovascular and cerebral events (MACCE)

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

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

Secondary Outcomes

  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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