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Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy (CCI impact)

Primary Purpose

Heart Failure, Resynchronization Therapy, Assessment of Acute CRT Response

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cardiac resynchronization therapy device implantation
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure focused on measuring Heart failure, Bundle branch block, CRT response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CRT implantation

Arm Description

Standard CRT indication. Assessment of acute response to CRT.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 1, 2013
Last Updated
March 30, 2016
Sponsor
Oslo University Hospital
Collaborators
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01996397
Brief Title
Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
Acronym
CCI impact
Official Title
Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Resynchronization Therapy, Assessment of Acute CRT Response
Keywords
Heart failure, Bundle branch block, CRT response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT implantation
Arm Type
Other
Arm Description
Standard CRT indication. Assessment of acute response to CRT.
Intervention Type
Procedure
Intervention Name(s)
Cardiac resynchronization therapy device implantation
Primary Outcome Measure Information:
Title
dP\dt max response to different ventricular lead pacing sites
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lead movements and electrical measures
Description
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.
Time Frame
6 months
Title
Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation
Description
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.
Time Frame
6 months
Title
Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
15152059
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. doi: 10.1056/NEJMoa032423.
Results Reference
background
PubMed Identifier
15753115
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. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
Results Reference
background
PubMed Identifier
12063368
Citation
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.
Results Reference
background
PubMed Identifier
20421518
Citation
Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, Leon 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.
Results Reference
background
PubMed Identifier
11748094
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. doi: 10.1161/hc5001.102229.
Results Reference
background
PubMed Identifier
15485432
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. doi: 10.1046/j.1540-8167.2004.04089.x.
Results Reference
background
PubMed Identifier
20298819
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.
Results Reference
background
PubMed Identifier
19215835
Citation
Mullens W, Verga T, Grimm RA, Starling RC, Wilkoff BL, Tang WHW. Persistent hemodynamic benefits of cardiac resynchronization therapy with disease progression in advanced heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):600-607. doi: 10.1016/j.jacc.2008.08.079.
Results Reference
background
PubMed Identifier
21184174
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.
Results Reference
background
PubMed Identifier
21884950
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.
Results Reference
background
PubMed Identifier
21791536
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.
Results Reference
background
PubMed Identifier
15851221
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. doi: 10.1016/j.hrthm.2004.07.002.
Results Reference
background
PubMed Identifier
16635996
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. doi: 10.1093/europace/eul017.
Results Reference
background
PubMed Identifier
16709698
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. doi: 10.1136/hrt.2005.080721. Epub 2006 May 18.
Results Reference
background
PubMed Identifier
20667892
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.
Results Reference
background
PubMed Identifier
20176716
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.
Results Reference
background
PubMed Identifier
16500302
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. doi: 10.1016/j.hrthm.2005.11.025.
Results Reference
background
PubMed Identifier
22126664
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.
Results Reference
background
PubMed Identifier
17552884
Citation
Tysler M, Kneppo P, Turzova M, Svehlikova J, Karas S, Heblakova E, Hana K, Filipova S. Noninvasive assessment of local myocardium repolarization changes using high resolution surface ECG mapping. Physiol Res. 2007;56 Suppl 1:S133-S141. doi: 10.33549/physiolres.931312. Epub 2007 May 31.
Results Reference
background
PubMed Identifier
19843927
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.
Results Reference
background
Links:
URL
http://www.heart-sfi.no/
Description
Center for Cardiological Innovation
URL
http://www.oslo-universitetssykehus.no
Description
Oslo University Hospital

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

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