Non-valvular Atrial Fibrillation
Conditions
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.
Interventions
DEVICEWatchman FLX
Patients who are receiving the Watchman FLX device
Sponsors
Premier Research
Iqvia Pty Ltd
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| procedural success | 7 days post-implant |
| incidence of stroke, leak, thrombus and death | 1 year |
| procedural complications | 7-days post implant |
Countries
Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed