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A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy (IDEAL-CRT)

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ClinicalTrials.gov Identifier: NCT02061241
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : October 20, 2015
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Dr James Gamble, Oxford University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment
Heart Failure Procedure: Pacing in vein at site of latest mechanical activation Procedure: Pacing in other suitable vein

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Patients
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
Pacing in vein at site of latest mechanical activation

Procedure: Pacing in other suitable vein
Pacing in other suitable vein




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response [ Time Frame: Time 0 (during implant procedure) ]
    To assess if further increases in acute haemodynamic response at the site of latest mechanical activation can be achieved with different pacing configurations.

  2. Acute haemodynamic response by NICOM and pressure wire [ Time Frame: Time 0 (during implant procedure) ]
    To compare results attained from non-invasive cardiac output monitoring (NICOM) to those from invasive monitoring

  3. Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm [ Time Frame: 1 day post procedure ]
    To assess the effect of right ventricular pacing on the site of latest mechanical activation. Assessed using speckle-tracking echocardiography.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Due to have CRT device implants.
Criteria

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)

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): NCT02061241


Locations
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United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 7AT
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Tim R Betts, MBChB, MD Oxford University Hospitals

Publications:
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Responsible Party: Dr James Gamble, Co-investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02061241     History of Changes
Other Study ID Numbers: NIHR CSP 146533
14/SC/0148 ( Other Identifier: UK NRES )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Dr James Gamble, Oxford University Hospitals NHS Trust:
Cardiac resynchronisation therapy
Pacing

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases