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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: ECHO optimisation; Other: Non-invasive haemodynamic optimisation

• Registration Number: NCT01258829
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Status Verified: 2014-05
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ECHO optimisation	ECHO optimisation	Optimization of AV/VV delay using the guideline recommendations
Non-invasive haemodynamic optimisation	Non-invasive haemodynamic optimisation	Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation

Primary Outcome Measures

Name	Time	Method
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation	6 months following the last follow-up of the last patient

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ICCH, Imperial College London; 🇬🇧 London, United Kingdom