PFO device closure in cerebrovascular events version 1
Research type
Research Study
Full title
PFO device closure benefits in prevention of recurrence of cryptogenic TIAs and strokes
IRAS ID
155304
Contact name
Tara Bharucha
Contact email
Sponsor organisation
R and D department - Southampton General Hospital
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
This research aims to evaluate how effective the procedure of preventing recurrence of stoke and mini strokes in people who have had a particular type of "hole in the heart" (a Patent foramen ovale, PFO) closed using a medical device.
The hole in the heart starts off as a necessary opening inside the heart of the unborn child. It allows blood to flow from the right side of the heart to the left side without passing through the lungs. This happens because the lungs in the unborn child are not yet fully developed to carry out their intended function of exchanging oxygen and carbon dioxide.
The hole normally closes shortly after the baby is born. However, in some people, this hole does not fully close. Some people actually grow into adulthood and live full lives with this open hole in the heart without experiencing any problems at all, especially if it is relatively small. It has been found that about 24% of adults may have this condition in the general population, and the majority have no problems at all.
It has also been found that having this hole in the heart raises the risk of having a stroke or mini stroke, or their recurrence if one has occurred. This is because this hole can allow a blood clot to travel from the right side of the heart to the left and proceed to the brain.
To prevent strokes and mini strokes from recurring in people who have this type of hole in the heart, the hole can be closed using a device.
This project will follow up on people who have been treated through this method to see whether some of them have experienced any further strokes or mini strokes since their procedure.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0041
Date of REC Opinion
20 Feb 2015
REC opinion
Further Information Favourable Opinion