An observational study in Heart Failure, sponsored by Oxford University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-20.
Sponsored by Oxford University Hospitals NHS Trust · Observational
Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT.
Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information.
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed.
This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 22 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Oxford University Hospitals NHS Trust is the lead sponsor of 92 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Due to have CRT device implants.
Exclusion Criteria:
All included patients, having CRT implant procedure Will have both Pacing in vein at site of latest mechanical activation and Pacing in other suitable vein.
Procedure: Pacing in vein at site of latest mechanical activation · Procedure: Pacing in other suitable vein
Pacing in vein at site of latest mechanical activation
Pacing in other suitable vein
Acute haemodynamic response in area of latest mechanical activation and another vein
To assess whether pacing at the site of latest mechanical activation produces the maximal acute haemodynamic response to biventricular pacing, when compared to other attainable Left Ventricular coronary venous pacing sites. Acute haemodynamic response measured as percentage change in left ventricular dP/dt max (maximum rate of change of left ventricular pressure) recorded by a left ventricular pressure wire, between baseline atrial pacing at 80 beats per minute and biventricular pacing in each vein
Time frame: Time 0 (during implant procedure)
Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response
To assess if further increases in acute haemodynamic response at the site of latest mechanical activation can be achieved with different pacing configurations.
Time frame: Time 0 (during implant procedure)
Acute haemodynamic response by NICOM and pressure wire
To compare results attained from non-invasive cardiac output monitoring (NICOM) to those from invasive monitoring
Time frame: Time 0 (during implant procedure)
Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm
To assess the effect of right ventricular pacing on the site of latest mechanical activation. Assessed using speckle-tracking echocardiography.
Time frame: 1 day post procedure
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Oxford University Hospitals NHS Trust