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

NCT02654470 | Completed

• 1 other identifier: FLXibility
• Study Type: observational
• Target: 300
• Locations: 9 countries
• Sites: 17

Brief Summary

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• procedural success

  7 days post-implant

• incidence of stroke, leak, thrombus and death

  1 year

• procedural complications

  7-days post implant

Interventions

Watchman FLX DEVICE

Patients who are receiving the Watchman FLX device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Premier Research: collaborator
• Iqvia Pty Ltd: collaborator

Study Sites (17)

Aarhus University Hospital

Aarhus, Denmark

Location

Hospices Civils de Lyon

Lyon, France

Location

Elisabeth Krankenhaus

Essen, Germany

Location

Cardio Vasculares Centrum Sankt Katharinen

Frankfurt, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Cardiologicum Hamburg

Hamburg, 22041, Germany

Location

Uni Jena

Jena, Germany

Location

Herzzentrum Universität Leipzig

Leipzig, Germany

Location

Beaumont Hospital

Dublin, Ireland

Location

Ospedale San Raffaele

Milan, Italy

Location

Ospedale San Francesco

Nuoro, Italy

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Clinical Hospital University of Medicine

Poznan, Poland

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Study Officials

• Timothy Betts

  John Radcliffe Hospital, Oxford, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: July 16, 2019
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FR (1); IT (2); ES (2); PL (1); DE (6); NL (1); GB (2); IE (1)