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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258829
First Posted: December 13, 2010
Last Update Posted: June 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
Imperial College London
  Purpose

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.


Condition Intervention
Heart Failure Other: Non-invasive haemodynamic optimisation Other: ECHO optimisation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 403
Study Start Date: December 2010
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-invasive haemodynamic optimisation
Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation
Other: Non-invasive haemodynamic optimisation
Comparing the method of non-invasive haemodynamic
Active Comparator: ECHO optimisation
Optimization of AV/VV delay using the guideline recommendations
Other: ECHO optimisation
Standard ECHO optimisation method

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258829


Locations
United Kingdom
ICCH, Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
University of Aberdeen
Investigators
Principal Investigator: Dr Darrel Francis Imperial College London
  More Information