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Completed

NCT Number: NCT02654470

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

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
  • 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;
  • Subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion criteria

  • 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
  • The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
  • Documented life expectancy of less than 12 months.

Treatment and study plan

Watchman FLX

Device

Patients who are receiving the Watchman FLX device

Primary outcomes

  1. procedural success

    Time frame: 7 days post-implant

  2. incidence of stroke, leak, thrombus and death

    Time frame: 1 year

  3. procedural complications

    Time frame: 7-days post implant

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • IQVIA Pty Ltd
  • Premier Research

Registry information

Official study title

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2016
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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