CATALYST
Research type
Research Study
Full title
Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonistoral anticoagulants
IRAS ID
282017
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Abbott Medical UK
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 4 months, 31 days
Research summary
The objective of this trial is to evaluate the safety and effectiveness of the Amulet device compared to blood thinning medication (NOAC) therapy in patients with non-valvular atrial fibrillation, which can be described as heart flutter, whom are at increased risk of stroke and who are recommended for long-term blood thinning medication.
The principal investigator or authorised designee, will screen the patient against the inclusion and exclusion criteria. The PI or designee will discuss the study with those patients that meet the eligibility criteria and follow the informed consent procedure detailed in ISO 14155. Participants that have completed written informed consent for the study will then be randomised to the amulet device "Device" Group or blood thinning oral anticoagulant medication (NOACs)"Control" Group. Some patients will be "Roll in" patients should the implanting physician have no experience with the amulet device.
Participants will receive follow up as per standard of care. Telephone appointments will be conducted and questionnaires administered. Images and data on imaging will be requested as part of the study but the imaging conducted will be done as standard of care. Participants will be part of the study for up to 5 years.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/1164
Date of REC Opinion
26 Jan 2021
REC opinion
Further Information Favourable Opinion