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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

Tracking Information
First Submitted Date February 7, 2014
First Posted Date February 12, 2014
Last Update Posted Date October 20, 2015
Study Start Date April 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 10, 2014)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy
Official Title Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Due to have CRT device implants.
Condition Heart Failure
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Pacing in vein at site of latest mechanical activation
  • Procedure: Pacing in other suitable vein
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 10, 2014)
22
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02061241
Other Study ID Numbers NIHR CSP 146533
14/SC/0148 ( Other Identifier: UK NRES )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr James Gamble, Oxford University Hospitals NHS Trust
Study Sponsor Oxford University Hospitals NHS Trust
Collaborators National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Tim R Betts, MBChB, MD Oxford University Hospitals
PRS Account Oxford University Hospitals NHS Trust
Verification Date October 2015