Electrophysiological Optimization of Left Ventricular Lead Placement in CRT

NCT02346097 | Completed DMC

• 1 other identifier: Electro-1-CRT
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate if "optimal electrical resynchronization" achieved by targeting left ventricular lead placement to the myocardial region with the latest electrical activation combined with post-implant pacemakersettings for narrowing the paced QRS width causes an excess improvement in the pumping function of the heart (the left ventricular ejection fraction) in Cardiac Resynchronization Therapy (CRT)

Conditions

Congestive Heart Failure

Keywords

Cardiac Resynchronization Therapy; Heart Failure; Ejection Fraction; Narrow; Pacemaker; Electrophysiology; Electrical activation mapping; Coronary Sinus; Mapping; QRS; QRS width; Pacing Interval; Left Ventricular Lead; Cardiac CT; Echocardiography; Myocardial Scintigraphy; 6 Minutes Walk Test; Imaging; Left ventricular ejection fraction; Epicardial veins; Resynchronization; ImagingCRT; Optimal electrical resynchronization; Cardiac computed tomography

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Change in LVEF determined by 2D echocardiography

  The day before implantation and 6 months after implantation

Secondary Outcomes (14)

• All cause mortality

  6 months and until "3 years and 6 months" after implantation

• Hospitalization for heart failure

  6 months and until "3 years and 6 months" after implantation

• CRT-implant procedure time

  The day of implantation

• Procedural radiation exposure

  The day of implantation

• Perioperative and late complications

  The day of implantation, 6 months and until "3 years and 6 months" after implantation

Study Arms (2)

Optimal electrical resynchronization

EXPERIMENTAL

Cardiac Resynchronization Therapy: LV lead implant according to electrical activation mapping of available epicardial veins to identify the latest electrical activated myocardial region. Post-implant interventricular (VV) electrical optimization for narrowing the paced QRS width. Post-implant standard pacemaker settings: Atrioventricular (AV) interval 100-130 ms and VV interval settings with simultaneous biventricular pacing. Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position. Programming of the VV interval to obtain the narrowest QRS-width

Device: Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead)

Routine CRT-strategy, imaging guided

ACTIVE COMPARATOR

Cardiac Resynchronization Therapy: LV lead implant guided by echocardiography and Rb-PET towards the latest mechanically activated myocardial segment and separate from scar. Post-implant VV electrical optimization for narrowing the paced QRS width. Standard pacemaker settings for both groups: AV-interval 100-130 ms and VV-interval settings with simultaneous biventricular pacing. Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position. Continue standard interventricular pacing interval settings with simultaneous pacing in both ventricular leads.

Device: Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead)

Interventions

Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead) DEVICE

Optimal electrical resynchronization vs. routine CRT strategy, imaging guided. For more details refer to ""Arm descriptions"

Also known as: St. Jude Qaudripolar LV lead

Optimal electrical resynchronization; Routine CRT-strategy, imaging guided

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic heart failure (New York Heart Association (NYHA) functional class II - IV) despite optimal medical therapy
• ECG with left bundle branch block and QRS ≥ 120 ms
• LVEF ≤ 35 %
• Age \> 40 years
• Written informed consent Patients with an indwelling single- or dual chamber pacemaker and a paced QRS \> 180 ms are eligible for enrollment.

You may not qualify if:

• Expected lifetime \< 6 months
• Expected heart-surgery within the next 6 months
• Recent (\< 3 months) myocardial infarction or coronary artery bypass graft (CABG)
• Pregnant or lactating
• No written informed consent Cardiac CT will not be performed in patients where this is contraindicated, i.e. in the presence of depressed renal function (estimated Glomerular Filtration Rate (eGFR) \< 30 ml (milliters)/minute), thyrotoxicosis or in the case of former serious reactions to the contrast media.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital, Skejby, Department of Cardiology

Aarhus, 8200, Denmark

Location

Related Publications (16)

• European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Europace. 2013 Aug;15(8):1070-118. doi: 10.1093/europace/eut206. Epub 2013 Jun 24. No abstract available.

  PMID: 23801827 BACKGROUND

• 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: 12063368 BACKGROUND

• Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.

  PMID: 15152059 BACKGROUND

• 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: 15753115 BACKGROUND

• Yu CM, Sanderson JE, Gorcsan J 3rd. Echocardiography, dyssynchrony, and the response to cardiac resynchronization therapy. Eur Heart J. 2010 Oct;31(19):2326-37. doi: 10.1093/eurheartj/ehq263. Epub 2010 Aug 13.

  PMID: 20709721 BACKGROUND

• Kronborg MB, Mortensen PT, Kirkfeldt RE, Nielsen JC. Very long term follow-up of cardiac resynchronization therapy: clinical outcome and predictors of mortality. Eur J Heart Fail. 2008 Aug;10(8):796-801. doi: 10.1016/j.ejheart.2008.06.013. Epub 2008 Jul 10.

  PMID: 18619900 BACKGROUND

• Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.

  PMID: 24347317 BACKGROUND

• Gold MR, Birgersdotter-Green U, Singh JP, Ellenbogen KA, Yu Y, Meyer TE, Seth M, Tchou PJ. The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy. Eur Heart J. 2011 Oct;32(20):2516-24. doi: 10.1093/eurheartj/ehr329. Epub 2011 Aug 29.

  PMID: 21875862 BACKGROUND

• Kandala J, Upadhyay GA, Altman RK, Parks KA, Orencole M, Mela T, Kevin Heist E, Singh JP. QRS morphology, left ventricular lead location, and clinical outcome in patients receiving cardiac resynchronization therapy. Eur Heart J. 2013 Aug;34(29):2252-62. doi: 10.1093/eurheartj/eht123. Epub 2013 Apr 9.

  PMID: 23571836 BACKGROUND

• Kronborg MB, Nielsen JC, Mortensen PT. Electrocardiographic patterns and long-term clinical outcome in cardiac resynchronization therapy. Europace. 2010 Feb;12(2):216-22. doi: 10.1093/europace/eup364. Epub 2009 Nov 14.

  PMID: 19915182 BACKGROUND

• Tamborero D, Vidal B, Tolosana JM, Sitges M, Berruezo A, Silva E, Castel M, Matas M, Arbelo E, Rios J, Villacastin J, Brugada J, Mont L. Electrocardiographic versus echocardiographic optimization of the interventricular pacing delay in patients undergoing cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2011 Oct;22(10):1129-34. doi: 10.1111/j.1540-8167.2011.02085.x. Epub 2011 Jun 2.

  PMID: 21635609 BACKGROUND

• Tamborero D, Mont L, Sitges M, Silva E, Berruezo A, Vidal B, Delgado V, Tolosana JM, Godoy M, Castel A, Brugada J. Optimization of the interventricular delay in cardiac resynchronization therapy using the QRS width. Am J Cardiol. 2009 Nov 15;104(10):1407-12. doi: 10.1016/j.amjcard.2009.07.006.

  PMID: 19892059 BACKGROUND

• Ypenburg C, Schalij MJ, Bleeker GB, Steendijk P, Boersma E, Dibbets-Schneider P, Stokkel MP, van der Wall EE, Bax JJ. Impact of viability and scar tissue on response to cardiac resynchronization therapy in ischaemic heart failure patients. Eur Heart J. 2007 Jan;28(1):33-41. doi: 10.1093/eurheartj/ehl379. Epub 2006 Nov 22.

  PMID: 17121757 BACKGROUND

• Bravo PE, Chien D, Javadi M, Merrill J, Bengel FM. Reference ranges for LVEF and LV volumes from electrocardiographically gated 82Rb cardiac PET/CT using commercially available software. J Nucl Med. 2010 Jun;51(6):898-905. doi: 10.2967/jnumed.109.073858. Epub 2010 May 19.

  PMID: 20484424 BACKGROUND

• Sommer A, Kronborg MB, Norgaard BL, Gerdes C, Mortensen PT, Nielsen JC. Left and right ventricular lead positions are imprecisely determined by fluoroscopy in cardiac resynchronization therapy: a comparison with cardiac computed tomography. Europace. 2014 Sep;16(9):1334-41. doi: 10.1093/europace/euu056. Epub 2014 Mar 30.

  PMID: 24687965 BACKGROUND

• Stephansen C, Sommer A, Kronborg MB, Jensen JM, Bouchelouche K, Nielsen JC. Electrically guided versus imaging-guided implant of the left ventricular lead in cardiac resynchronization therapy: a study protocol for a double-blinded randomized controlled clinical trial (ElectroCRT). Trials. 2018 Nov 1;19(1):600. doi: 10.1186/s13063-018-2930-y.

  PMID: 30382923 DERIVED

MeSH Terms

Conditions

Heart Failure; Aortic Coarctation

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Jens Cosedis Nielsen, Professor

  Aarhus University Hospital, Sekjby, Department of Cardiology

  STUDY DIRECTOR

• Mads Brix Kronborg, MD, PhD

  Aarhus University Hospital, Sekjby, Department of Cardiology

  STUDY DIRECTOR

• Anders Sommer Knudsen, MD

  Aarhus University Hospital, Sekjby, Department of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 26, 2015
• Study Start: February 16, 2015
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

DK (1)