Clinical trial NCT02654470: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)
Official title: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
name: Iqvia Pty Ltd
First posted: 2016-01-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: procedural success
timeFrame: 7 days post-implant
measure: incidence of stroke, leak, thrombus and death
timeFrame: 1 year
measure: procedural complications
timeFrame: 7-days post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Frankfurt
country: Germany
facility: Cardio Vasculares Centrum Sankt Katharinen
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Jena
country: Germany
facility: Uni Jena
city: Leipzig
country: Germany
facility: Herzzentrum Universität Leipzig
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Poznan
country: Poland
facility: Clinical Hospital University of Medicine
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: John Radcliffe Hospital, Oxford, UK
name: Timothy Betts
role: PRINCIPAL_INVESTIGATOR
References: