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Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654470
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
Premier Research Group plc
Iqvia Pty Ltd
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Condition or disease Intervention/treatment
Non-valvular Atrial Fibrillation Device: Watchman FLX

Detailed Description:
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Watchman FLX
    Patients who are receiving the Watchman FLX device


Primary Outcome Measures :
  1. procedural success [ Time Frame: 7 days post-implant ]
    per Munich consensus paper (percentage)

  2. incidence of stroke, leak, thrombus and death [ Time Frame: 1 year ]
    per Munich consensus paper (rate per 100 PY)

  3. procedural complications [ Time Frame: 7-days post implant ]
    per Munich consensus paper (percentage)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:   Probability Sample
Study Population
All subjects who meet all inclusion and no exclusion criteria can be enrolled. A subject who signs informed consent is considered enrolled in the study. The subjects selected for participation will be from the investigator's general patient population.
Criteria

Inclusion Criteria:

  1. Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
  2. Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
  3. Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  1. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject 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. The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
  3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
  4. Documented life expectancy of less than 12 months.

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): NCT02654470


Contacts
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Contact: Raffaella Falciglia +410216510160 raffaella.falciglia@bsci.com
Contact: Elisa Vireca, MS +3224167011 elisa.vireca@bsci.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Premier Research Group plc
Iqvia Pty Ltd
Investigators
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Principal Investigator: Timothy Betts John Radcliffe Hospital, Oxford, UK
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02654470    
Other Study ID Numbers: FLXibility
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: May 2020
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