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

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654470
• Other study ID #: FLXibility
• Status: Completed
• Start date: July 16, 2019
• Est. completion date: September 28, 2021

Study information

• Verified date: November 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
France	Hospices Civils de Lyon	Lyon
Germany	Elisabeth Krankenhaus	Essen
Germany	Cardio Vasculares Centrum Sankt Katharinen	Frankfurt
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Germany	Cardiologicum Hamburg	Hamburg
Germany	Uni Jena	Jena
Germany	Herzzentrum Universität Leipzig	Leipzig
Ireland	Beaumont Hospital	Dublin
Italy	Ospedale San Raffaele	Milan
Italy	Ospedale San Francesco	Nuoro
Netherlands	St. Antonius Hospital	Nieuwegein
Poland	Clinical Hospital University of Medicine	Poznan
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Virgen Macarena	Sevilla
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Iqvia Pty Ltd, Premier Research Group plc

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedural success		7 days post-implant
Primary	incidence of stroke, leak, thrombus and death		1 year
Primary	procedural complications		7-days post implant