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出境医 / 临床实验 / Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai (LAAO-SH)

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

Study Description
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.
Study Design
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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
Arms 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.
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date June 14, 2019
First Posted Date June 17, 2019
Last Update Posted Date June 17, 2019
Actual Study Start Date May 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2019) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 14, 2019)
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with NVAF who are referred for LAAO procedure.
Condition
  • 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.
Study Groups/Cohorts Left atrial appendage occlusion
Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure.
Intervention: Device: left atrial appendage occlusion devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 14, 2019) 		150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03987945
Other Study ID Numbers LAAO-SH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ya-Wei Xu, Shanghai 10th People's Hospital
Study Sponsor Shanghai 10th People's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yawei Xu, M.D., Ph.D. Department of Cardiology, Shanghai Tenth People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date June 2019

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