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

Imperial College London

Status: Completed

Conditions: Heart Failure

Treatments: Other: ECHO optimisation; Other: Non-invasive haemodynamic optimisation

Study type: Interventional

Funder types: Other

Identifiers

NCT01258829

10/H0803/86

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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403 participants in 2 patient groups

Non-invasive haemodynamic optimisation

Experimental group

Description:

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

Treatment:

Other: Non-invasive haemodynamic optimisation

ECHO optimisation

Active Comparator group

Description:

Optimization of AV/VV delay using the guideline recommendations

Treatment:

Other: ECHO optimisation