Status:
WITHDRAWN
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-100 years
Brief Summary
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 ...
Detailed Description
Principal study aim: To document the impact of the next generation of Watchman LAAC device on key aspects of the implant procedure Study Rationale: As an interventional procedure it is important that...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03339193
Start Date
January 1 2016
End Date
June 1 2016
Last Update
November 13 2017
Active Locations (1)
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1
Department of Cardiology, John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU