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Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy (RAISE-CRT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Prof. Michael Glikson, Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603706
First Posted: May 22, 2012
Last Update Posted: July 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Rambam Health Care Campus
Kaplan Medical Center
Soroka University Medical Center
Mayo Clinic
Information provided by (Responsible Party):
Prof. Michael Glikson, Sheba Medical Center
  Purpose
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.

Condition Intervention
Ischemic Cardiomyopathy Procedure: Echo guided implantation group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Radial Strain Imaging-Guided Lead Placement for Improving Response to Cardiac Resynchronization Therapy in Patients With Ischemic Cardiomyopathy: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Prof. Michael Glikson, Sheba Medical Center:

Primary Outcome Measures:
  • Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values. [ Time Frame: within 12 month from enrollment. ]
    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.


Secondary Outcome Measures:
  • Clinical Improvement [ Time Frame: Within 12 month from enrollment ]
    A combined clinical event rate - change in NYHA, hospitalization for heart failure, death

  • Echocardiographic improvement [ Time Frame: Within 12 month from enrollment ]
    >15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF

  • Improvement in wellbeing [ Time Frame: Within 12 month from enrollment ]
    10 point improvement in Minnesota Living with Heart Failure Questionnaire (MLWHF), 10% improvement of 6 minute walk test(6MWT)


Estimated Enrollment: 212
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Echo guided implantation group
Echo guided implantation group Patients undergoing speckle tracking based LV lead implantation.
Procedure: Echo guided implantation group
Lead placement according echo strain imaging result
No Intervention: Conventional implantation group
Patients undergoing conventional LV lead implantation

Detailed Description:

In this study we propose to evaluate the utility of radial strain imaging using speckle tracking 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, and to determine the value of lead localization determined by radial strain imaging in a prospective, randomized manner. We will compare two randomized groups of CRT recipients implanted with CRT-D systems. In the control group, implantation will be performed in the usual manner and the lead will be placed at the discretion of the implanting physician, preferably at posterolateral LV sites . In the study group, leads will be placed in areas of latest contraction that lack significant scar, as determined by speckle tracking imaging. The primary outcome measure for comparison between the 2 groups will be echocardiographic response (as assessed by percent reduction in left ventricular end systolic volumes) at 6 months post-implantation. In addition, clinical response parameters will also be measured as secondary end points.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603706


Contacts
Contact: Michael Glikson, MD 972-3-5302608 mglikson@post.tau.ac.il

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paul Friedman, MD    507-284-2511    friedman.paul@mayo.edu   
Principal Investigator: Paul Friedman, MD         
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel
Contact: Orna Tubul       ornitc@barzi.health.gov.il   
Principal Investigator: Vladimir Halamazer, MD         
Carmel Medical Center Not yet recruiting
Haifa, Israel
Contact: Mali Aizenhook       MaliAz@clalit.org.il   
Principal Investigator: Arie Militiano, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Monther Boulos, MD    972-4-8543474    m_boulos@rambam.health.gov.il   
Principal Investigator: Monther Boulos, MD         
Shaare Zedek Recruiting
Jerusalem, Israel
Contact: Astrid       astrid@szmc.org.il   
Principal Investigator: Aharon Medina, MD         
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Gregory Golovchiner, MD    972-3-9377108    golovgry@gmail.com   
Principal Investigator: Gregory Golovchiner, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Michael Glikson, MD    972-3-5302608    mglikson@post.tau.ac.il   
Principal Investigator: Michael Glikson, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Moshe Swissa, MD    972-8-9441883    swissam@clalit.org.il   
Principal Investigator: Dr. Moshe Swissa, MD         
Sorasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Sami Viskin, MD    972-3-6973311    saviskin@tasmc.health.gov.il   
Principal Investigator: Sami Viskin, MD         
Sponsors and Collaborators
Sheba Medical Center
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Rambam Health Care Campus
Kaplan Medical Center
Soroka University Medical Center
Mayo Clinic
Investigators
Study Director: Ilan Goldenberg, Prof. The Israeli Society for the Prevention of Heart Attacks
Principal Investigator: Michael Glikson, Prof. Sheba Medical Center
Principal Investigator: Paul Friedman, Prof. Mayo Clinic
  More Information

Publications:
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. Review.
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.
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, Kühl HP, Grawe H, Katoh M, Kramann R, Bücker 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. 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, Jánosi 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.
Kindermann M, Fröhlig 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.

Responsible Party: Prof. Michael Glikson, Prof. Michael Glikson, MD., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01603706     History of Changes
Other Study ID Numbers: SHEBA-12-9349-MG-CTIL
First Submitted: May 14, 2012
First Posted: May 22, 2012
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Prof. Michael Glikson, Sheba Medical Center:
Heart failure
Cardiac Resynchronization Therapy
CRT
Radial strain echocardiography
Ischemic cardiomyopathy

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases


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