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Clinical Trials/NCT02061241
NCT02061241CompletedNot Applicable

Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT

Oxford University Hospitals NHS Trust1 site in 1 country22 target enrollmentStarted: April 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Acute haemodynamic response in area of latest mechanical activation and another vein

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • With ejection fraction <35%
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Indication for cardiac resynchronisation therapy

Exclusion Criteria

  • Left Ventricular Ejection Fraction >35%
  • Severe peripheral vascular disease (that would make arterial access more risky)
  • Haemodynamic instability (such that a longer procedure is inadvisable)

Outcomes

Primary Outcomes

Acute haemodynamic response in area of latest mechanical activation and another vein

Time Frame: Time 0 (during implant procedure)

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

Secondary Outcomes

  • Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm(1 day post procedure)
  • Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response(Time 0 (during implant procedure))
  • Acute haemodynamic response by NICOM and pressure wire(Time 0 (during implant procedure))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr James Gamble

Co-investigator

Oxford University Hospitals NHS Trust

Study Sites (1)

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