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

NCT ID: NCT02654470

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2021-09-28

Brief Summary

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Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Detailed Description

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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.

Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Watchman FLX

Patients who are receiving the Watchman FLX device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Premier Research Group plc

UNKNOWN

Sponsor Role collaborator

Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Betts

Role: PRINCIPAL_INVESTIGATOR

John Radcliffe Hospital, Oxford, UK

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Elisabeth Krankenhaus

Essen, , Germany

Site Status

Cardio Vasculares Centrum Sankt Katharinen

Frankfurt, , Germany

Site Status

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Site Status

Cardiologicum Hamburg

Hamburg, , Germany

Site Status

Uni Jena

Jena, , Germany

Site Status

Herzzentrum Universität Leipzig

Leipzig, , Germany

Site Status

Beaumont Hospital

Dublin, , Ireland

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

Ospedale San Francesco

Nuoro, , Italy

Site Status

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Clinical Hospital University of Medicine

Poznan, , Poland

Site Status

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Virgen Macarena

Seville, , Spain

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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Denmark France Germany Ireland Italy Netherlands Poland Spain United Kingdom

Other Identifiers

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FLXibility

Identifier Type: -

Identifier Source: org_study_id