Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device — REFLX  

Stroke Clinical Trial

Official title: Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device

Status Withdrawn

Clinical Trial 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 of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

• NCT number: NCT03339193
• Study type: Observational [Patient Registry]
• Source: Oxford University Hospitals NHS Trust
• Status: Withdrawn
• Phase: N/A
• Start date: January 2016
• Completion date: June 2016