Stroke Clinical Trial
Official title:
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
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.
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 progressive steps are
made to make the procedure safer, simpler, faster and more cost-effective. This study will
document the impact of introducing the next generation of LAAC device, the Watchman FLX, into
a clinical service. It is anticipated that the increased versatility of the Watchman FLX will
lead to fewer repositionings and redeployments, shortening procedure time and reducing the
mean number of devices opened per case.
Patients to be enrolled: Consecutive patients implanted with the Watchman FLX. All patients
will meet current United Kingdom guidelines for LAAC, i.e. have atrial fibrillation, a high
risk of thromboembolic stroke (CHA2DS2VASc score >2) and contraindications to long-term oral
anticoagulation.
Study design: This is a prospective single-centre observational case-controlled study to be
conducted at the John Radcliffe Hospital, Oxford, United Kingdom
Outcomes: Data collected will include patient demographics, left atrial appendage (LAA)
dimensions and anatomical description, total procedure duration, device implant time (from
introduction of Access sheath to cable release), number of devices opened/ used, number of
repositions and redeployments, final position, presence of residual leak, acute
complications, peri- and post-procedure antiplatelet and anticoagulant use and 6 week
transesophageal echo findings. There will be a particular focus on the need for repositioning
and redeployment and how that is undertaken (e.g. advancement of device distally into the
LAA).
Timelines: For 20 patients in each group, 7 months from first patient enrolled to final
patient undergoing 6 week transesophageal echo (TEE) followup will be required.
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