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Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096963
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in Hong Kong area.

Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation Device: The WATCHMAN FLX Delivery System

Detailed Description:
This study is a prospective, non-randomized, multi-center observational study. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.The primary safety endpoint is the occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Secondary effectiveness endpoint is the occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observe the Safety and Effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Stroke in Hong Kong Area
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
The WATCHMAN FLX Delivery System
Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;
Device: The WATCHMAN FLX Delivery System
WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium




Primary Outcome Measures :
  1. The occurrence of non-effective LAA closure defined as any peri-device flow > 5mm [ Time Frame: First Follow-up (30 ~ 100 days); ]
    The occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with non-valvular atrial fibrillation to reduce the risk of stroke
Criteria

Inclusion Criteria:

  1. Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;
  2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
  3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  1. Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
  2. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
  3. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

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): NCT04096963


Locations
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China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Chan Chin Pang Gary Prince of Wales Hospital
Principal Investigator: Fung Chi Yan Raymond Princess Margaret Hospital, Canada
Principal Investigator: Tsui Kin Lam Pamela Youde Nethersole Hospital
Principal Investigator: Simon Lam Queen Mary Hospital, Hong Kong
Principal Investigator: Michael Lee Queen Elizabeth Hospital

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04096963     History of Changes
Other Study ID Numbers: S2461
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes