Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device (REFLX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03339193|
Recruitment Status : Withdrawn
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Stroke||Device: Left atrial appendage closure|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Target Follow-Up Duration:||2 Months|
|Official Title:||Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Patients having LAAC
Patients who meet current clinical criteria for left atrial appendage closure (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 OUH NHS Foundation Trust LAAC Multidisciplinary Team (MDT) as suitable for left atrial appendage occlusion in accordance with National Health Service (NHS) guidelines.
Device: Left atrial appendage closure
Percutaneous insertion of a Watchman FLX left atrial appendage closure device under general anesthesia with transesophageal echo guidance.
- Procedural success rates, (redeployments and devices used) [ Time Frame: Implant procedure ]Implant characteristics. This is a descriptive study
- Procedural characteristics (including number of repositions), [ Time Frame: Implant procedure ]Implant characteristics. This is a descriptive study
- Procedure complications [ Time Frame: Implant procedure ]Implant characteristics. This is a descriptive study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339193
|Department of Cardiology, John Radcliffe Hospital|
|Oxford, United Kingdom, OX3 9DU|
|Study Director:||Tim Betts, MD||Oxford University Hospitals NHS Trust|