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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Principal Investigator: Tim R Betts, MBChB, MD; Oxford University Hospitals

More Information

Publications:

Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.

McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.

Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.

Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.

• Responsible Party: Dr James Gamble, Co-investigator, Oxford University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02061241
• Other Study ID Numbers: NIHR CSP 146533; 14/SC/0148 ( Other Identifier: UK NRES )
• First Posted: February 12, 2014
• 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:

Heart Failure; Heart Diseases; Cardiovascular Diseases