Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— CCI impact  

Official title:

Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996397
• Other study ID #: 2013/140
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: March 30, 2016
• Start date: May 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines

• Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.

• Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.

• Subject (or the legal guardian) is willing to sign informed consent form

Exclusion Criteria:

• Permanent atrial fibrillation/ flutter or tachycardia

• RBBB

• Recent myocardial infarction (MI), within 40 days prior to enrollment. Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment

• Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year

• Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year

• On chronic renal dialysis, or with severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2)

• On continuous or uninterrupted infusion (inotropic) therapy for heart failure (= 2 stable infusions a week)

• Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)

• Complex and uncorrected congenital heart disease

• Mechanical heart valve

• Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control

• Enrolled in one or more concurrent studies that would confound the results of this study

• Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Assessment of Acute CRT Response
• Heart Failure
• Resynchronization Therapy

Intervention

Procedure:
• Cardiac resynchronization therapy device implantation

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Medtronic Bakken Research Center

Country where clinical trial is conducted

Norway, 

References & Publications (20)

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. — View Citation

Blendea D, Singh JP. Lead positioning strategies to enhance response to cardiac resynchronization therapy. Heart Fail Rev. 2011 May;16(3):291-303. doi: 10.1007/s10741-010-9212-4. Review. — View Citation

Bocchiardo M, Meyer zu Vilsendorf D, Militello C, Lippert M, Czygan G, Schauerte P, Gaita F, Stellbrink C. Resynchronization therapy optimization by intracardiac impedance. Europace. 2010 Nov;12(11):1589-95. doi: 10.1093/europace/euq273. Epub 2010 Jul 28. — View Citation

Bogaard MD, Houthuizen P, Bracke FA, Doevendans PA, Prinzen FW, Meine M, van Gelder BM. Baseline left ventricular dP/dtmax rather than the acute improvement in dP/dtmax predicts clinical outcome in patients with cardiac resynchronization therapy. Eur J Heart Fail. 2011 Oct;13(10):1126-32. doi: 10.1093/eurjhf/hfr094. Epub 2011 Jul 26. — View Citation

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. — View Citation

Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. — View Citation

Butter C, Stellbrink C, Belalcazar A, Villalta D, Schlegl M, Sinha A, Cuesta F, Reister C. Cardiac resynchronization therapy optimization by finger plethysmography. Heart Rhythm. 2004 Nov;1(5):568-75. — View Citation

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. Epub 2005 Mar 7. — View Citation

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. — View Citation

Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, León AR, Oshinski JN. Agreement is poor among current criteria used to define response to cardiac resynchronization therapy. Circulation. 2010 May 11;121(18):1985-91. doi: 10.1161/CIRCULATIONAHA.109.910778. Epub 2010 Apr 26. — View Citation

Jia P, Ramanathan C, Ghanem RN, Ryu K, Varma N, Rudy Y. Electrocardiographic imaging of cardiac resynchronization therapy in heart failure: observation of variable electrophysiologic responses. Heart Rhythm. 2006 Mar;3(3):296-310. — View Citation

Merchant FM, Heist EK, McCarty D, Kumar P, Das S, Blendea D, Ellinor PT, Mela T, Picard MH, Ruskin JN, Singh JP. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm. 2010 May;7(5):639-44. doi: 10.1016/j.hrthm.2010.01.035. Epub 2010 Feb 1. — View Citation

Mullens W, Verga T, Grimm RA, Starling RC, Wilkoff BL, Tang WH. Persistent hemodynamic benefits of cardiac resynchronization therapy with disease progression in advanced heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):600-7. doi: 10.1016/j.jacc.2008.08.079. — View Citation

Rossillo A, Verma A, Saad EB, Corrado A, Gasparini G, Marrouche NF, Golshayan AR, McCurdy R, Bhargava M, Khaykin Y, Burkhardt JD, Martin DO, Wilkoff BL, Saliba WI, Schweikert RA, Raviele A, Natale A. Impact of coronary sinus lead position on biventricular pacing: mortality and echocardiographic evaluation during long-term follow-up. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1120-5. — View Citation

Shetty AK, Duckett SG, Ma YL, Kapetanakis S, Ginks M, Bostock J, Carr-White G, Rhode K, Razavi R, Rinaldi CA. The acute hemodynamic response to LV pacing within individual branches of the coronary sinus using a quadripolar lead. Pacing Clin Electrophysiol. 2012 Feb;35(2):196-203. doi: 10.1111/j.1540-8159.2011.03268.x. Epub 2011 Nov 29. — View Citation

Turcott RG, Witteles RM, Wang PJ, Vagelos RH, Fowler MB, Ashley EA. Measurement precision in the optimization of cardiac resynchronization therapy. Circ Heart Fail. 2010 May;3(3):395-404. doi: 10.1161/CIRCHEARTFAILURE.109.900076. Epub 2010 Feb 22. — View Citation

Tysler M, Kneppo P, Turzová M, Svehlíková J, Karas S, Hebláková E, Hána K, Filipová S. Noninvasive assessment of local myocardium repolarization changes using high resolution surface ECG mapping. Physiol Res. 2007;56 Suppl 1:S133-41. Epub 2007 May 31. — View Citation

van Deursen C, van Geldorp IE, Rademakers LM, van Hunnik A, Kuiper M, Klersy C, Auricchio A, Prinzen FW. Left ventricular endocardial pacing improves resynchronization therapy in canine left bundle-branch hearts. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):580-7. doi: 10.1161/CIRCEP.108.846022. Epub 2009 Aug 10. — View Citation

Whinnett ZI, Davies JE, Willson K, Chow AW, Foale RA, Davies DW, Hughes AD, Francis DP, Mayet J. Determination of optimal atrioventricular delay for cardiac resynchronization therapy using acute non-invasive blood pressure. Europace. 2006 May;8(5):358-66. — View Citation

Whinnett ZI, Davies JE, Willson K, Manisty CH, Chow AW, Foale RA, Davies DW, Hughes AD, Mayet J, Francis DP. Haemodynamic effects of changes in atrioventricular and interventricular delay in cardiac resynchronisation therapy show a consistent pattern: analysis of shape, magnitude and relative importance of atrioventricular and interventricular delay. Heart. 2006 Nov;92(11):1628-34. Epub 2006 May 18. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dP\dt max response to different ventricular lead pacing sites	To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site.	6 months	Yes
Secondary	Lead movements and electrical measures	Compare metrics derived from 2/3-D reconstructions of lead movement to electrical measures (e.g. Q-LV-timing or VCG) at different pacing configurations in patients undergoing a CRT-implant.	6 months	No
Secondary	Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation	To compare metrics derived from 2/3-D reconstructions of lead movement to Force-Interval-Relation at different pacing configurations in patients undergoing a CRT-implant.	6 months	No
Secondary	Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map	To compare metrics derived from 2/3-D reconstructions of lead movement to CardioGuide Motion Map at different pacing configurations in patients undergoing a CRT-implant.	6 months	No

External Links

•   Center for Cardiological Innovation
•   Oslo University Hospital