Stroke Clinical Trial
— REFLXOfficial title:
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
Verified date | March 2017 |
Source | Oxford University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Patients who meet current clinical criteria for LAAC, ie have atrial fibrillation, a
CHA2DS2-VASc score of 3 or more and a contraindication to long-term oral anticoagulation
therapy and who have been approved by the Oxford University Hospitals (OUH) NHS Foundation
Trust LAAC MDT as suitable for left atrial appendage occlusion in accordance with NHS
guidelines. A subject will be considered for enrolment in the study if all of the following inclusion criteria are met, provided no exclusion criteria are met: Inclusion Criteria: - Subjects who are eligible for a WATCHMAN FLX device per physician discretion according to current international and local guidelines and currently approved indications - Subjects 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 - Subjects whose age is 18 years or above, or of legal age to give informed consent specific to national law. Exclusion Criteria: - Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. - Subjects who are unable or not willing to complete the follow-up visits and examination at 6 weeks. - Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion). - Documented life expectancy of less than 12 months. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Cardiology, John Radcliffe Hospital | Oxford |
Lead Sponsor | Collaborator |
---|---|
Oxford University Hospitals NHS Trust | Boston Scientific Corporation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural success rates, (redeployments and devices used) | Implant characteristics. This is a descriptive study | Implant procedure | |
Primary | Procedural characteristics (including number of repositions), | Implant characteristics. This is a descriptive study | Implant procedure | |
Secondary | Procedure complications | Implant characteristics. This is a descriptive study | Implant procedure |
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