NCT02174289

Brief Summary

Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. Lack of clinical response may be the result of imperfect left ventricular lead placement in the veins around the heart with conventional techniques. Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred heart muscle or may not be at the site of latest electrical depolarisation. In a further 10% of patients, conventional left ventricular lead placement is not possible for other technical reasons. Left ventricular endocardial lead placement may overcome the limitations and allow placement to be guided by echocardiography, electrical mapping and the pattern of heart muscle scarring. We aim to investigate if targeted left ventricular endocardial lead placement improves exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency and biochemical markers of heart strain. Each parameter will be assessed independently and as part of a composite cardiac performance score. Patients with heart failure will be enrolled who require an endocardial left ventricular lead on clinical grounds as either conventional left ventricular lead implantation has technically failed or they have clinically non-responded to CRT.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

June 24, 2014

Last Update Submit

June 26, 2014

Conditions

Heart Failure

Keywords

Heart FailureCardiac Resynchronisation TherapyTransseptal left ventricular endocardial lead

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary Exercise Test

    Improvement in peak oxygen consumption

    3 months

Secondary Outcomes (7)

  • New NYHA Class

    3 months

  • 6 minute walk

    3 months

  • Quality of life

    3 months

  • Echocardiography

    3 months

  • Digital photoplethysmography

    3 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Freedom from adverse events

    1 year

  • Medium term clinical outcomes

    6 months

  • Targeting success

    Intra operative

Study Arms (2)

Active Bi-ventricular Pacing

ACTIVE COMPARATOR
Device: Targeted left ventricular endocardial lead placement

No Biventricular pacing

PLACEBO COMPARATOR
Device: Targeted left ventricular endocardial lead placement

Interventions

Targeted left ventricular endocardial lead placementDEVICE

The left ventricular endocardial lead will be passed through the intra-atrial septum

Active Bi-ventricular PacingNo Biventricular pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • NYHA class II-IV
  • LVEF ≤35%
  • QRS ≥120 milliseconds
  • Optimal tolerated medical therapy
  • Either unable to position an LV lead via the standard coronary sinus on CRT implantation
  • OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
  • Informed consent

You may not qualify if:

  • Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
  • Previous atrial septal defect device closure.
  • Chronic renal dialysis and End stage liver disease
  • History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
  • Presence of correctable valvular disease (aortic/mitral)
  • Mitral valve prosthesis.
  • Contra indication to vitamin K antagonist
  • Unresolved intra-cardiac thrombus
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (10)

  • Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.

    PMID: 15753115BACKGROUND

  • McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

    PMID: 22611136BACKGROUND

  • Gras D, Bocker D, Lunati M, Wellens HJ, Calvert M, Freemantle N, Gervais R, Kappenberger L, Tavazzi L, Erdmann E, Cleland JG, Daubert JC; CARE-HF Study Steering Committee and Investigators. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace. 2007 Jul;9(7):516-22. doi: 10.1093/europace/eum080. Epub 2007 May 31.

    PMID: 17540662BACKGROUND

  • Jais P, Douard H, Shah DC, Barold S, Barat JL, Clementy J. Endocardial biventricular pacing. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 1):2128-31. doi: 10.1111/j.1540-8159.1998.tb01133.x.

    PMID: 9826866BACKGROUND

  • van Gelder BM, Scheffer MG, Meijer A, Bracke FA. Transseptal endocardial left ventricular pacing: an alternative technique for coronary sinus lead placement in cardiac resynchronization therapy. Heart Rhythm. 2007 Apr;4(4):454-60. doi: 10.1016/j.hrthm.2006.11.023. Epub 2006 Nov 29.

    PMID: 17399634BACKGROUND

  • Nuta B, Lines I, MacIntyre I, Haywood GA. Biventricular ICD implant using endocardial LV lead placement from the left subclavian vein approach and transseptal puncture via the transfemoral route. Europace. 2007 Nov;9(11):1038-40. doi: 10.1093/europace/eum176. Epub 2007 Aug 17.

    PMID: 17704095BACKGROUND

  • Jais P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haissaguerre M, Clementy J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1744-7. doi: 10.1111/j.1540-8159.2000.tb07010.x.

    PMID: 11139915BACKGROUND

  • Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014.

    PMID: 20797490BACKGROUND

  • 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

  • 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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tom Wong, MD FESC

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Butcher, MBBS MRCP

CONTACT

c.butcher@rbht.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 25, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

GB(1)