Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy
NCT ID: NCT01603706
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2012-05-31
2017-10-31
Brief Summary
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Detailed Description
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We hypothesize that 1) patients showing greater dyssynchrony and/or discoordination index with speckle tracking will derive a significantly greater response to cardiac resynchronization therapy; and 2) patients allocated to the image-guided LV lead placement group will derive a significantly greater response to CRT than patients in the non- guided implantation (control) group.
If radial strain imaging proves useful for improving the CRT response rate and identification of patients likely to respond, it will have important clinical and economic implications by improving individual outcomes and more effective utilization of constrained health care resources. Furthermore, if echo-guided lead implantation proves to be effective in reducing the relatively large non-response rate to cardiac resynchronization therapy, it will likely result in increased device utilization among eligible heart failure patients.
Specific Aims Aim #1: To show that in patients with ischemic cardiomyopathy, implantation of a CRT LV lead guided by radial strain imaging results in a significantly greater echocardiographic and clinical response to cardiac resynchronization therapy compared with conventional implantation techniques.
Aim #2: To show that speckle tracking strain data can be used to identify the degree of echocardiographic response to CRT, using both dyssynchrony (time to peak strain ) and discoordination indices.
Aim #3:
The Paieon substudy will comprise 40 patients enrolled at 3 centers, for whom additional information mechanical dyssynchrony, using the Paieon CardioGuide motion map, will be collected during device implantation as detailed below The primary aim of the study is to relate data of mechanical dyssynchrony obtained from angiography through the Paieon CardioGuide motion map to dyssynchrony data obtained from the echocardiogram.
The dyssynchrony data will not be available to the treating physicians and will not be used to direct the LV lead location.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Echo guided implantation group
Echo guided implantation group Patients undergoing speckle tracking based LV lead implantation.
Echo guided implantation group
Lead placement according echo strain imaging result
Conventional implantation group
Patients undergoing conventional LV lead implantation
No interventions assigned to this group
Interventions
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Echo guided implantation group
Lead placement according echo strain imaging result
Eligibility Criteria
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Inclusion Criteria
* AHA ACC or ESC EHRA Guideline-based indication (Class I or II) for CRT and NYHA class II-IV heart failure
* ECG wide QRS and :
QRS \> 120 msec in NYHA III- IV
OR
CLBBB or QRS \> 150 in NYHA =II
* Sinus rhythm predominant rhythm (PAF not an exclusion)
* All must be candidates for De novo CRT-D implantation with LV lead via transvenous approach or patients previously implanted with pacemaker or ICD with \<20% pacing over the last three months who are undergoing CRT-D upgrade.
* Patient provides informed consent, tolerate a pectoral implant, agree to comply with the protocol, and maintain scheduled follow-up visits.
Exclusion Criteria
* Advanced renal disease (Cr \>=2.5 mg/dL)
* Advanced comorbidities with life expectancy of \<1 year
* Patients on waiting list for heart transplantation
* Requiring intravenous amines (continuous or or intermittent amine drip therapy)
* Severe chronic pulmonary disease (simulating heart failure)
* Severe (untreated) organic mitral valve disease
* Poorly treated hypertension
* History of myocardial infarction \< 3 months; unstable angina \< 1m, CABG \<3 months; PCI \<3 months
* Mechanical TC valve
* Previously implanted CRT system
* Poorly visualized cardiac chamber dimensions in an echocardiogram performed prior to enrollment - please help us define
* Pregnancy or child-bearing potential in the absence of accepted forms of birth control
* Concurrent enrollment in other study
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Rabin Medical Center
OTHER
Rambam Health Care Campus
OTHER
Kaplan Medical Center
OTHER
Soroka University Medical Center
OTHER
Mayo Clinic
OTHER
Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof. Michael Glikson
Prof. Michael Glikson, MD.
Principal Investigators
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Ilan Goldenberg, Prof.
Role: STUDY_DIRECTOR
The Israeli Society for the Prevention of Heart Attacks
Michael Glikson, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Paul Friedman, Prof.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Barzilai Medical Center
Ashkelon, , Israel
Carmel Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Shaare Zedek
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sorasky Medical Center
Tel Aviv, , Israel
Countries
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References
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Miyazaki C, Redfield MM, Powell BD, Lin GM, Herges RM, Hodge DO, Olson LJ, Hayes DL, Espinosa RE, Rea RF, Bruce CJ, Nelson SM, Miller FA, Oh JK. Dyssynchrony indices to predict response to cardiac resynchronization therapy: a comprehensive prospective single-center study. Circ Heart Fail. 2010 Sep;3(5):565-73. doi: 10.1161/CIRCHEARTFAILURE.108.848085. Epub 2010 Jul 20.
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.
Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
Delgado V, van Bommel RJ, Bertini M, Borleffs CJ, Marsan NA, Arnold CT, Nucifora G, van de Veire NR, Ypenburg C, Boersma E, Holman ER, Schalij MJ, Bax JJ. Relative merits of left ventricular dyssynchrony, left ventricular lead position, and myocardial scar to predict long-term survival of ischemic heart failure patients undergoing cardiac resynchronization therapy. Circulation. 2011 Jan 4;123(1):70-8. doi: 10.1161/CIRCULATIONAHA.110.945345. Epub 2010 Dec 20.
Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
Delgado V, Ypenburg C, van Bommel RJ, Tops LF, Mollema SA, Marsan NA, Bleeker GB, Schalij MJ, Bax JJ. Assessment of left ventricular dyssynchrony by speckle tracking strain imaging comparison between longitudinal, circumferential, and radial strain in cardiac resynchronization therapy. J Am Coll Cardiol. 2008 May 20;51(20):1944-52. doi: 10.1016/j.jacc.2008.02.040.
Tanaka H, Nesser HJ, Buck T, Oyenuga O, Janosi RA, Winter S, Saba S, Gorcsan J 3rd. Dyssynchrony by speckle-tracking echocardiography and response to cardiac resynchronization therapy: results of the Speckle Tracking and Resynchronization (STAR) study. Eur Heart J. 2010 Jul;31(14):1690-700. doi: 10.1093/eurheartj/ehq213. Epub 2010 Jun 8.
Kirn B, Jansen A, Bracke F, van Gelder B, Arts T, Prinzen FW. Mechanical discoordination rather than dyssynchrony predicts reverse remodeling upon cardiac resynchronization. Am J Physiol Heart Circ Physiol. 2008 Aug;295(2):H640-6. doi: 10.1152/ajpheart.00106.2008. Epub 2008 May 30.
Wang CL, Wu CT, Yeh YH, Wu LS, Chang CJ, Ho WJ, Hsu LA, Luqman N, Kuo CT. Recoordination rather than resynchronization predicts reverse remodeling after cardiac resynchronization therapy. J Am Soc Echocardiogr. 2010 Jun;23(6):611-20. doi: 10.1016/j.echo.2010.03.012. Epub 2010 Apr 24.
Wang CL, Powell BD, Redfield MM, Miyazaki C, Fine NM, Olson LJ, Cha YM, Espinosa RE, Hayes DL, Hodge DO, Lin G, Friedman PA, Oh JK. Left ventricular discoordination index measured by speckle tracking strain rate imaging predicts reverse remodelling and survival after cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):517-25. doi: 10.1093/eurjhf/hfs025. Epub 2012 Mar 12.
Sung RK, Foster E. Assessment of systolic dyssynchrony for cardiac resynchronization therapy is not clinically useful. Circulation. 2011 Feb 15;123(6):656-62. doi: 10.1161/CIRCULATIONAHA.110.954420. No abstract available.
Kindermann M, Frohlig G, Doerr T, Schieffer H. Optimizing the AV delay in DDD pacemaker patients with high degree AV block: mitral valve Doppler versus impedance cardiography. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2453-62. doi: 10.1111/j.1540-8159.1997.tb06085.x.
Other Identifiers
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SHEBA-12-9349-MG-CTIL
Identifier Type: -
Identifier Source: org_study_id