NCT03415945

Brief Summary

In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein. LV septal pacing may be a good alternative for BiV pacing in patients with an indication for CRT.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2017

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

First Submitted

Initial submission to the registry

January 23, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2020

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

January 23, 2017

Last Update Submit

February 9, 2018

Conditions

Heart FailureCardiac Resynchronization TherapyLeft Bundle-Branch Block

Outcome Measures

Primary Outcomes (1)

  • Acute hemodynamic effect (LV dP/dtmax) of the best LV septal pacing side and conventional BiV pacing.

    A RadiAnalyzer Physio monitor version 2.02 (St. Jude Medical, St. Paul, USA) is used to calculate LV dP/dtmax as a measure of LV systolic function.

    The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).

Secondary Outcomes (2)

  • Acute hemodynamic effects (LV dP/dtmax) of the different LV septal pacing sides with RV apical septum pacing, His pacing, RV septum pacing, LV epicardial postero-lateral wall pacing and intrinsic ventricular activation.

    The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).

  • The effect on the sequence of LV electrical activation and body surface electrocardiographic mapping

    The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).

Study Arms (1)

CRT implantation

EXPERIMENTAL

In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) posterolateral wall.

Device: Cardiac resynchronization therapy (CRT)

Interventions

Cardiac resynchronization therapy (CRT)DEVICE

All study participants have a clinical indication for CRT and will receive CRT implantation as part of their routine medical care. Additionally, participants will receive temporary left and right ventricular septal pacing electrodes and a temporary PressureWire to investigate the acute hemodynamic effect of left ventricular septal pacing, using patients as their own controls.

CRT implantation

Eligibility Criteria

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

You may qualify if:

  • Chronic heart failure with NYHA functional class II-IV
  • Left ventricular ejection fraction (LVEF) \< 35%
  • LBBB and QRS duration ≥ 130 ms or non-LBBB and QRS duration ≥ 150 ms
  • In sinus rhythm
  • Optimal pharmacological therapy

You may not qualify if:

  • Persistent atrial fibrillation
  • ≥ 2 premature ventricular complexes on standard 12-lead electrocardiogram (ECG)
  • Age \< 18 years
  • Incapable of giving informed consent
  • Moderate to severe aortic valve stenosis
  • Peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

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

  • Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.

    PMID: 12063368BACKGROUND

  • Mills RW, Cornelussen RN, Mulligan LJ, Strik M, Rademakers LM, Skadsberg ND, van Hunnik A, Kuiper M, Lampert A, Delhaas T, Prinzen FW. Left ventricular septal and left ventricular apical pacing chronically maintain cardiac contractile coordination, pump function and efficiency. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):571-9. doi: 10.1161/CIRCEP.109.882910. Epub 2009 Aug 25.

    PMID: 19843926BACKGROUND

  • Mafi-Rad M, Luermans JG, Blaauw Y, Janssen M, Crijns HJ, Prinzen FW, Vernooy K. Feasibility and Acute Hemodynamic Effect of Left Ventricular Septal Pacing by Transvenous Approach Through the Interventricular Septum. Circ Arrhythm Electrophysiol. 2016 Mar;9(3):e003344. doi: 10.1161/CIRCEP.115.003344.

    PMID: 26888445BACKGROUND

  • Strik M, Rademakers LM, van Deursen CJ, van Hunnik A, Kuiper M, Klersy C, Auricchio A, Prinzen FW. Endocardial left ventricular pacing improves cardiac resynchronization therapy in chronic asynchronous infarction and heart failure models. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):191-200. doi: 10.1161/CIRCEP.111.965814. Epub 2011 Nov 7.

    PMID: 22062796BACKGROUND

  • Strik M, van Deursen CJ, van Middendorp LB, van Hunnik A, Kuiper M, Auricchio A, Prinzen FW. Transseptal conduction as an important determinant for cardiac resynchronization therapy, as revealed by extensive electrical mapping in the dyssynchronous canine heart. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):682-9. doi: 10.1161/CIRCEP.111.000028. Epub 2013 Jul 19.

    PMID: 23873141BACKGROUND

  • Singh JP, Fan D, Heist EK, Alabiad CR, Taub C, Reddy V, Mansour M, Picard MH, Ruskin JN, Mela T. Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy. Heart Rhythm. 2006 Nov;3(11):1285-92. doi: 10.1016/j.hrthm.2006.07.034. Epub 2006 Aug 10.

    PMID: 17074633BACKGROUND

  • Kors JA, van Herpen G, Sittig AC, van Bemmel JH. Reconstruction of the Frank vectorcardiogram from standard electrocardiographic leads: diagnostic comparison of different methods. Eur Heart J. 1990 Dec;11(12):1083-92. doi: 10.1093/oxfordjournals.eurheartj.a059647.

    PMID: 2292255BACKGROUND

  • Man S, Algra AM, Schreurs CA, Borleffs CJ, Scherptong RW, van Erven L, van der Wall EE, Cannegieter SC, Schalij MJ, Swenne CA. Influence of the vectorcardiogram synthesis matrix on the power of the electrocardiogram-derived spatial QRS-T angle to predict arrhythmias in patients with ischemic heart disease and systolic left ventricular dysfunction. J Electrocardiol. 2011 Jul-Aug;44(4):410-5. doi: 10.1016/j.jelectrocard.2011.04.007.

    PMID: 21704219BACKGROUND

  • Schreurs CA, Algra AM, Man SC, Cannegieter SC, van der Wall EE, Schalij MJ, Kors JA, Swenne CA. The spatial QRS-T angle in the Frank vectorcardiogram: accuracy of estimates derived from the 12-lead electrocardiogram. J Electrocardiol. 2010 Jul-Aug;43(4):294-301. doi: 10.1016/j.jelectrocard.2010.03.009. Epub 2010 Apr 24.

    PMID: 20417936BACKGROUND

MeSH Terms

Conditions

Heart FailureBundle-Branch Block

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Kevin Vernooy, MD, PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Floor Salden, MD

CONTACT

+31-43-3884520floor.salden@mumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 30, 2018

Study Start

November 23, 2017

Primary Completion

May 23, 2019

Study Completion

May 23, 2020

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

NL(1)