NCT02061241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

February 7, 2014

Last Update Submit

October 16, 2015

Conditions

Heart Failure

Keywords

Cardiac resynchronisation therapyPacing

Outcome Measures

Primary Outcomes (1)

  • 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 0 (during implant procedure)

Secondary Outcomes (3)

  • 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)

  • Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm

    1 day post procedure

Study Arms (1)

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 activationProcedure: Pacing in other suitable vein

Interventions

Pacing in vein at site of latest mechanical activationPROCEDURE

Pacing in vein at site of latest mechanical activation

Patients
Pacing in other suitable veinPROCEDURE

Pacing in other suitable vein

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Due to have CRT device implants.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7AT, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 22405632BACKGROUND

  • 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.

    PMID: 17565085BACKGROUND

  • 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.

    PMID: 23476053BACKGROUND

  • 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.

    PMID: 21884950BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tim R Betts, MBChB, MD

    Oxford University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 12, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

GB(1)