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

Completed

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT02654470
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

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.

Study Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Study Start: 2019-07-16
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
procedural complications	7-days post implant
procedural success	7 days post-implant
incidence of stroke, leak, thrombus and death	1 year

Trial Locations

Locations (17)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hospital De La Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Elisabeth Krankenhaus; 🇩🇪 Essen, Germany

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Herzzentrum Universität Leipzig; 🇩🇪 Leipzig, Germany

Uni Jena; 🇩🇪 Jena, Germany

Cardio Vasculares Centrum Sankt Katharinen; 🇩🇪 Frankfurt, Germany

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Germany

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Ospedale San Francesco; 🇮🇹 Nuoro, Italy

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Hospices Civils de Lyon; 🇫🇷 Lyon, France

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Clinical Hospital University of Medicine; 🇵🇱 Poznan, Poland