Device optimisation in patients with ACHD
Research type
Research Study
Full title
Device optimisation in patients with adult congenital heart disease
IRAS ID
213670
Contact name
Samuel Griffiths
Contact email
Sponsor organisation
Royal Brompton & Harefield NHS Foundation Trust
Duration of Study in the UK
4 years, 10 months, 12 days
Research summary
Congenital heart disease is the most prevalent defect at birth, affecting greater than 1% of children. As a result of improvements in diagnosis, surgical techniques and medical management there are now more adults than children with new and growing health needs.
Due to major differences in the hearts structure many of these patients develop heart rhythm disturbances and/or an impaired pumping ability of the heart. These include slow heart rates, fast abnormal heart rhythms and a decline in heart function that can negatively impact a patient’s quality of life and increase the risk of sudden death.
Implanted electronic cardiac devices (pacemakers, implantable defibrillators and cardiac resynchronisation therapy (CRT) devices) are often used to treat these conditions. They use electrical pulses to stimulate the heart to help prevent slow heart rates, terminate fast rhythms and synchronise the heartbeat. Evidence suggests they can improve the ability of the heart to pump blood and provide oxygen to the body, thereby reducing patient symptoms.
Previous research has shown that personalised device optimisation may be able to further improve the health of these patients. In particular, optimising the timings of the electrical pulses between the top and bottom chambers of the heart (known as the atrioventricular delay) may be beneficial. This has been shown in patients born with structurally normal hearts but there have been no prospective studies in those with adult congenital heart disease (ACHD).
Patients will undergo device optimisation and a series of tests to evaluate their exercise capacity and heart function. They will then repeat the tests six weeks later to determine the effect device optimisation has on their health. This will indicate whether personalised device optimisation is clinically useful in the ACHD population and may inform future clinical care for ACHD patients with devices.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/0341
Date of REC Opinion
19 Apr 2017
REC opinion
Further Information Favourable Opinion