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NCT Number: NCT01258829

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICCH, Imperial College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive haemodynamic optimisation

Other

Comparing the method of non-invasive haemodynamic

ECHO optimisation

Other

Standard ECHO optimisation method

Primary outcomes

  1. 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

  1. 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

    Time frame: 6 months following the last follow-up of the last patient

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • University of Aberdeen

Registry information

Official study title

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

Acronym: BRAVO

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2010
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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