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

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ClinicalTrials.gov Identifier: NCT03987945
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Left Atrial Appendage Occlusion 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. All-cause death [ 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 ]
    Death from any cause

  2. Cardiovascular death [ 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 ]
    Death from cardiovascular causes

  3. Ischemic stroke [ 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 ]
    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

  4. Major bleeding [ 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 ]
    The incidence of major bleeding as defined by BARC (3-5)

  5. Heart failure rehospitalization [ 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 ]
    Rehospitalization for heart failure

  6. Pericardial effusion [ 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 ]
    Pericardial effusion validated by echocardiography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with NVAF who are referred for LAAO procedure.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987945


Contacts
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Contact: Mengmeng Gong, M.D. +86-188-0179-0469 zoemodi@outlook.com

Locations
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China, Shanghai
Department of Cardiology, Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Mengmeng Gong, M.D.    +86-188-0179-0469    zoemodi@outlook.com   
Principal Investigator: Yawei Xu, M.D., Ph.D.         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Yawei Xu, M.D., Ph.D. Department of Cardiology, Shanghai Tenth People's Hospital

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Responsible Party: Ya-Wei Xu, Chief Physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03987945     History of Changes
Other Study ID Numbers: LAAO-SH
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
atrial fibrillation; left atrial appendage occlusion

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes