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

NCT01258829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2015-06-30

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Non-invasive haemodynamic optimisation

Comparing the method of non-invasive haemodynamic

OTHER

ECHO optimisation

Standard ECHO optimisation method

Sponsors & Collaborators

  • University of Aberdeen

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • Dr Darrel Francis · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258829 on ClinicalTrials.gov