Quartet Lead With Defibrillator Multisite Algorithmic Cardiac Resynchronisation Therapy Optimisation

NCT02997670 | Withdrawn

• 1 other identifier: 16/WA/0370 186610
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients with heart failure. However, around one third of suitable patients do not demonstrate benefit following device implantation when assessed by echocardiography (heart scanning). This group has poorer outcomes. Response rate can be enhanced by altering timing delays between the pacing leads, but some patients still fail to improve. Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles increase the number of conformations available to the programmer, allowing multiple vectors to be programmed simultaneously or sequentially. This allows programming to avoid, for example, a patch of scar and find an area that will respond better to pacing. This technique is known as multi-site pacing. CRT is often implanted along with a defibrillator lead in the right ventricle, known as CRT-D. The defibrillator lead offers further combinations for pacing. Goal of Research To evaluate an algorithm for assessing different multi-site pacing combinations in optimisation of CRT Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation for conventional indications at our hospital. At baseline, patients will undergo echocardiography, exercise testing and assessments of functional ability and quality of life. The device will be implanted as standard. Optimisation will be performed with an algorithm using different vector combinations and assessing the heart's efficiency through echocardiography and invasive pressure monitoring. The pacemaker will be programmed with standard settings. After twelve weeks, the baseline investigations and optimisation algorithm will be repeated and the device programmed according to the maximum efficiency. After a further 12 weeks, the same parameters will be measured to look for improved response to CRT. Potential Benefit To increase the response rate to cardiac resynchronisation therapy and improve reliability of the technique

Conditions

Heart Failure, Systolic

Keywords

Cardiac resynchronization pacing therapy

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular end-systolic volume in patients undergoing algorithmic optimisation of CRT-D compared with usual device settings

  End-systolic volume will be measured on echocardiography using Simpson's method. Where image quality precludes a full biplane assessment, single plane will be used with the apical 4-chamber view, or alternatively left ventricular end-systolic diameter will be used to calculate volume using the Teicholz method.

  24 weeks

Secondary Outcomes (16)

• Feasibility of algorithmic, echocardiography-guided CRT-D optimisation with quadripolar left ventricular leads in clinical practice

  24 weeks

• Correlation between invasive haemodynamic studies with non-invasive ultrasound-based methods in optimising CRT-D

  24 weeks

• Change in left ventricular end diastolic pressure with algorithmic optimisation of CRT-D compared with usual device settings

  24 weeks

• Feasibility of ultrasound cardiac output monitoring (USCOM) in optimisation of CRT devices in clinical practice

  At baseline and at 12 weeks

• Change in peak oxygen consumption with algorithmic CRT-D optimisation compared with usual device settings

  24 weeks

Study Arms (1)

Main patient cohort

EXPERIMENTAL

Algorithmic Cardiac Resynchronisation Therapy Optimisation; Patients requiring CRT-D enrolled to receive algorithmic CRT optimisation at their device implantation. They will then be programmed to standard CRT settings for 12 weeks. Assessments will be performed and they will again undergo CRT optimisation using the specified algorithm. This time, they will be programmed to the settings giving maximal cardiac output on echocardiography, as assessed by LVOT VTI. After a further 12 weeks, they will again undergo assessment and the study will terminate.

Other: Algorithmic Cardiac Resynchronisation Therapy Optimisation

Interventions

Algorithmic Cardiac Resynchronisation Therapy Optimisation OTHER

Use of a computer algorithm to run through multiple combinations of pacing options in patients who have a Cardiac resynchronisation pacemaker with defibrillator where a quadripolar lead has been implanted. These quadripolar leads offer extra options for pacing locations across the heart, as well as for different combinations and sequences of pacing stimuli.

Main patient cohort

Eligibility Criteria

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

You may qualify if:

• Successful implantation of CRT-D device with quadripolar left ventricular lead and dual coil right ventricular lead.

You may not qualify if:

• failed device implantation
• inability to complete the follow-up process
• inability to provide full written consent. Patients unable to perform cardiopulmonary exercise testing will be excluded from this assessment only and will be able to complete the remaining assessments.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (11)

• Auricchio A, Stellbrink C, Sack S, Block M, Vogt J, Bakker P, Huth C, Schondube F, Wolfhard U, Bocker D, Krahnefeld O, Kirkels H; Pacing Therapies in Congestive Heart Failure (PATH-CHF) Study Group. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol. 2002 Jun 19;39(12):2026-33. doi: 10.1016/s0735-1097(02)01895-8.

  PMID: 12084604 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

• Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K; Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003 May 28;289(20):2685-94. doi: 10.1001/jama.289.20.2685.

  PMID: 12771115 BACKGROUND

• Daubert C, Gold MR, Abraham WT, Ghio S, Hassager C, Goode G, Szili-Torok T, Linde C; REVERSE Study Group. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009 Nov 10;54(20):1837-46. doi: 10.1016/j.jacc.2009.08.011. Epub 2009 Oct 1.

  PMID: 19800193 BACKGROUND

• Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

  PMID: 19038680 BACKGROUND

• Chung ES, Katra RP, Ghio S, Bax J, Gerritse B, Hilpisch K, Peterson BJ, Feldman DS, Abraham WT. Cardiac resynchronization therapy may benefit patients with left ventricular ejection fraction >35%: a PROSPECT trial substudy. Eur J Heart Fail. 2010 Jun;12(6):581-7. doi: 10.1093/eurjhf/hfq009. Epub 2010 Feb 11.

  PMID: 20150328 BACKGROUND

• Osca J, Alonso P, Cano O, Andres A, Miro V, Tello MJ, Olague J, Martinez L, Salvador A. The use of multisite left ventricular pacing via quadripolar lead improves acute haemodynamics and mechanical dyssynchrony assessed by radial strain speckle tracking: initial results. Europace. 2016 Apr;18(4):560-7. doi: 10.1093/europace/euv211. Epub 2015 Sep 1.

  PMID: 26333378 BACKGROUND

• Rinaldi CA, Burri H, Thibault B, Curnis A, Rao A, Gras D, Sperzel J, Singh JP, Biffi M, Bordachar P, Leclercq C. A review of multisite pacing to achieve cardiac resynchronization therapy. Europace. 2015 Jan;17(1):7-17. doi: 10.1093/europace/euu197. Epub 2014 Sep 11.

  PMID: 25214507 BACKGROUND

• Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Saviano M, Baldi M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm. 2014 Mar;11(3):394-401. doi: 10.1016/j.hrthm.2013.11.023. Epub 2013 Nov 28.

  PMID: 24291411 BACKGROUND

• Siu CW, Tse HF, Lee K, Chan HW, Chen WH, Yung C, Lee S, Lau CP. Cardiac resynchronization therapy optimization by ultrasonic cardiac output monitoring (USCOM) device. Pacing Clin Electrophysiol. 2007 Jan;30(1):50-5. doi: 10.1111/j.1540-8159.2007.00579.x.

  PMID: 17241315 BACKGROUND

• Zanon F, Baracca E, Pastore G, Marcantoni L, Fraccaro C, Lanza D, Picariello C, Aggio S, Roncon L, Dell'Avvocata F, Rigatelli G, Pacetta D, Noventa F, Prinzen FW. Multipoint pacing by a left ventricular quadripolar lead improves the acute hemodynamic response to CRT compared with conventional biventricular pacing at any site. Heart Rhythm. 2015 May;12(5):975-81. doi: 10.1016/j.hrthm.2015.01.034. Epub 2015 Jan 24.

  PMID: 25625721 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Freya M Lodge, MBBS

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

• Zaheer R Yousef, MBBS

  Cardiff and Vale University Health Board

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 20, 2016
• Study Start: July 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)