British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO) (BRAVO)

British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO)

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

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.

Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation

Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation

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

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

Whinnett ZI, Sohaib SMA, Mason M, Duncan E, Tanner M, Lefroy D, Al-Obaidi M, Ellery S, Leyva-Leon F, Betts T, Dayer M, Foley P, Swinburn J, Thomas M, Khiani R, Wong T, Yousef Z, Rogers D, Kalra PR, Dhileepan V, March K, Howard J, Kyriacou A, Mayet J, Kanagaratnam P, Frenneaux M, Hughes AD, Francis DP. Multicenter Randomized Controlled Crossover Trial Comparing Hemodynamic Optimization Against Echocardiographic Optimization of AV and VV Delay of Cardiac Resynchronization Therapy: The BRAVO Trial. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1407-1416. doi: 10.1016/j.jcmg.2018.02.014. Epub 2018 May 16.

Jones S, Lumens J, Sohaib SMA, Finegold JA, Kanagaratnam P, Tanner M, Duncan E, Moore P, Leyva F, Frenneaux M, Mason M, Hughes AD, Francis DP, Whinnett ZI; BRAVO Investigators. Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function. Europace. 2017 Jul 1;19(7):1178-1186. doi: 10.1093/europace/euw136.

Whinnett ZI, Sohaib SM, Jones S, Kyriacou A, March K, Coady E, Mayet J, Hughes AD, Frenneaux M, Francis DP; BRAVO Investigators. British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints. BMC Cardiovasc Disord. 2014 Apr 3;14:42. doi: 10.1186/1471-2261-14-42.

Jones S, Shun-Shin MJ, Cole GD, Sau A, March K, Williams S, Kyriacou A, Hughes AD, Mayet J, Frenneaux M, Manisty CH, Whinnett ZI, Francis DP. Applicability of the iterative technique for cardiac resynchronization therapy optimization: full-disclosure, 50-sequential-patient dataset of transmitral Doppler traces, with implications for future research design and guidelines. Europace. 2014 Apr;16(4):541-50. doi: 10.1093/europace/eut257. Epub 2013 Sep 25.