Effect of HV optimisation in cardiac resynchronisation therapy
Research type
Research Study
Full title
A randomised cross-over pilot study of the effect of HV interval optimisation in cardiac resynchronisation therapy in patients with heart failure
IRAS ID
152412
Contact name
Theodora Nikolaidou
Contact email
Sponsor organisation
Research and Development Department, Hull and East Yorkshire Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 5 days
Research summary
Is HV interval optimisation in cardiac resynchronisation therapy beneficial in patients with heart failure?
Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssychrony). Currently, pacing timing between the upper and lower chambers of the heart with CRT is set empirically or by pacemaker-derived algorithms. None of these methods have been shown to improve symptoms or outcomes.
We propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. Participation is expected to last 1 year and will involve 2 additional hospital visits. During CRT implantation, additional measurements, including the His-Ventricular interval (HV interval) will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or HV-optimised settings with cross-over at 4 months. Participants will also undergo blood tests, a walking test, echocardiography and they will be asked to complete a questionnaire.
Our hypothesis is that patients with HV-optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings. If our hypothesis is true it will lead to a larger multi-site clinical trial with the aim of improving response and survival rates for CRT in patients with heart failure.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
16/YH/0185
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion