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

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation
• Intervention / Treatment: Device: Watchman FLX

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• France
  • Lyon, France
    • Hospices Civils de Lyon
• Germany
  • Essen, Germany
    • Elisabeth Krankenhaus
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Frankfurt, Germany
    • Cardio Vasculares Centrum Sankt Katharinen
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg
  • Jena, Germany
    • Uni Jena
  • Leipzig, Germany
    • Herzzentrum Universität Leipzig
• Ireland
  • Dublin, Ireland
    • Beaumont Hospital
• Italy
  • Milan, Italy
    • Ospedale San Raffaele
  • Nuoro, Italy
    • Ospedale San Francesco
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
• Poland
  • Poznan, Poland
    • Clinical Hospital University of Medicine
• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Sevilla, Spain
    • Hospital Virgen Macarena
• United Kingdom
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
procedural success	7 days post-implant
incidence of stroke, leak, thrombus and death	1 year
procedural complications	7-days post implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Iqvia Pty Ltd; Premier Research Group plc
• Investigators: Principal Investigator: Timothy Betts, John Radcliffe Hospital, Oxford, UK

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2019
• Primary Completion (ACTUAL): September 28, 2021
• Study Completion (ACTUAL): September 28, 2021

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (ESTIMATE): January 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: FLXibility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No