Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy

NCT01603706 | Completed

• 1 other identifier: SHEBA-12-9349-MG-CTIL
• Study Type: interventional
• Target: 172
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Thus assessing the value of lead localization determined by radial strain imaging in a prospective, randomized manner.

Conditions

Ischemic Cardiomyopathy

Keywords

Heart failure; Cardiac Resynchronization Therapy; CRT; Radial strain echocardiography; Ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values.

  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.

  within 12 month from enrollment.

Secondary Outcomes (3)

• Clinical Improvement

  Within 12 month from enrollment

• Echocardiographic improvement

  Within 12 month from enrollment

• Improvement in wellbeing

  Within 12 month from enrollment

Study Arms (2)

Echo guided implantation group

ACTIVE COMPARATOR

Echo guided implantation group Patients undergoing speckle tracking based LV lead implantation.

Procedure: Echo guided implantation group

Conventional implantation group

NO INTERVENTION

Patients undergoing conventional LV lead implantation

Interventions

Echo guided implantation group PROCEDURE

Lead placement according echo strain imaging result

Echo guided implantation group

Eligibility Criteria

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

You may qualify if:

• Patients with ischemic CMP based on evidence of prior MI by history, coronary angiography/revascularization or imaging
• 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
• CLBBB or QRS \> 150 in NYHA =II
• 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.

You may not qualify if:

• Permanent or persistent atrial fibrillation
• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Tel-Aviv Sourasky Medical Center: collaborator
• Rabin Medical Center: collaborator
• Rambam Health Care Campus: collaborator
• Kaplan Medical Center: collaborator
• Soroka University Medical Center: collaborator
• Mayo Clinic: collaborator

Study Sites (9)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Shaare Zedek

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Sorasky Medical Center

Tel Aviv, Israel

Location

Related Publications (12)

• 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

• 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.

  PMID: 20647479 BACKGROUND

• 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.

  PMID: 18458170 BACKGROUND

• 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.

  PMID: 21173353 BACKGROUND

• 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.

  PMID: 17035253 BACKGROUND

• 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.

  PMID: 18482662 BACKGROUND

• 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.

  PMID: 20530502 BACKGROUND

• 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.

  PMID: 18515652 BACKGROUND

• 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.

  PMID: 20418055 BACKGROUND

• 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.

  PMID: 22411692 BACKGROUND

• 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.

  PMID: 21321181 BACKGROUND

• 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.

  PMID: 9358487 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ilan Goldenberg, Prof.

  The Israeli Society for the Prevention of Heart Attacks

  STUDY DIRECTOR

• Michael Glikson, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Friedman, Prof.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Michael Glikson, MD.

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 22, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1); IL (8)