British Randomised Controlled Trial of AV and VV Optimisation (BRAVO): Randomised Clinical Trial of the Effects of Non-invasive Haemodynamic Optimisation of Cardiac Resynchronisation Devices on Exercise Capacity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Imperial College London
- Enrollment
- 403
- Locations
- 1
- Primary Endpoint
- Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. The most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. However, this is not frequently performed because it is time consuming and requires two skilled operators. In this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger).
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic heart failure due to systolic dysfunction
- •Biventricular pacemaker implanted
- •Give written informed consent
Exclusion Criteria
- •Lung disease or any condition that would preclude them from walking on a treadmill
Outcomes
Primary Outcomes
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation
Time Frame: 6 months following the last follow-up of the last patient
Secondary Outcomes
- To determine whether pressure optimisation is at least equivalent to echo optimisation of flow: in terms resulting size of the heart in terms of quality of life scores in terms of blood marker of heart failure severity(6 months following the last follow-up of the last patient)