Injectable Valve Implantation Trial (Invite)
Research type
Research Study
Full title
The effectiveness on post-operative recovery of using ‘off pump’ self-expanding tissue valves (IPVR) versus ‘on pump’ conventional tissue valves (PVR) for pulmonary valve replacement: a pilot randomised controlled trial (RCT)
IRAS ID
167604
Contact name
Diana Benton
Contact email
Sponsor organisation
UH BRISTOL NHS Foundation Trust*
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The majority of children born with a congenital heart defect (CHD) now live into adulthood. Many of them need repeated operations throughout life to replace the valves on the right side of the heart (pulmonary valves). The standard operation for valve replacement involves opening the chest, extensive exposure of the heart by the surgeon and use of the heart lung machine to take over the function of the heart and lungs (pumping blood and oxygen through the body) during the operation. However, repeated use of the heart lung machine is associated with complications, such as excessive bleeding, heart damage, stroke, and even death. Therefore, it is preferable to avoid using it if possible. Two new types of “injectable” self-expanding artificial valves have been developed to replace poorly functioning valves on the right side of the heart. These can be “injected” into position with the heart still beating (avoiding the need to use the heart lung machine) and without a need for the surgeon to expose all the heart.
We propose to conduct a type of study in which patients will be allocated at random (by chance) to receive either the “injectable” valve or standard valve. We will follow patients to determine whether the use of injectable valves results in quicker recovery and shorter stay in hospital and is cost-saving for the NHS. We will also determine whether these valves function as well as the conventional ones.
These new valves have not been extensively studied and we do not really know whether “injectable” valves really do achieve these benefits. Surgeons have reported their experiences but only for small numbers of patients and without comparing their experiences directly with the conventional replacement valves.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0179
Date of REC Opinion
16 Nov 2015
REC opinion
Further Information Favourable Opinion