SECURE (BWI_2019_05)
Research type
Research Study
Full title
An observational post-marketing study for evaluation of ongoing safety and effectiveness of catheter mapping and ablation using commercially approved BWI medical devices for the treatment of patients with cardiac arrhythmias
IRAS ID
291077
Contact name
Marjorie FALISE
Contact email
Sponsor organisation
Biosense Webster
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 9 months, 31 days
Research summary
This is a prospective, multi-center, non-randomized, observational, post-marketing study.
Prospective: The study follows over time a group of individuals who have a similar medical condition.
Multi-center: Several hospitals will be involved in this study.
Non-Randomized: The treatment will not be chosen at random, it will not be decided by chance.
Observational: No visit or assessment will be conducted specifically for the study. We will be looking at the information that would be collected according to the standard of care, even if the subject would not be participating in the study.
Post-marketing: All medical devices used in this study are already commercially available.
Study participants will have the ablation procedure according to the standard of care of their hospital and according to their physician’s preference. There is no specific assessment or intervention required specifically for the study.
This study gives a general structure to collect data of study participants that are treated for their irregular heart rhythm according to the hospital standard of care using medical devices of Biosense Webster that are available on the market.
The data collected with this study will be used to confirm the safety and performance of the medical devices of Biosense Webster that are available on the market.
Additionally, the data collected will broaden the evidence on the use of these devices and techniques to treat irregular heart rhythm.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0048
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion