Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy

Ischemic Cardiomyopathy Clinical Trial

— RAISE-CRT  

Official title:

Radial Strain Imaging-Guided Lead Placement for Improving Response to Cardiac Resynchronization Therapy in Patients With Ischemic Cardiomyopathy: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603706
• Other study ID #: SHEBA-12-9349-MG-CTIL
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: October 18, 2017
• Start date: May 2012
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

Procedure:
• Echo guided implantation group
Lead placement according echo strain imaging result

Locations

Country	Name	City	State
Israel	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
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
Sheba Medical Center	Kaplan Medical Center, Mayo Clinic, Rabin Medical Center, Rambam Health Care Campus, Soroka University Medical Center, Tel-Aviv Sourasky Medical Center

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Improvement	A combined clinical event rate - change in NYHA, hospitalization for heart failure, death	Within 12 month from enrollment
Secondary	Echocardiographic improvement	>15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF	Within 12 month from enrollment
Secondary	Improvement in wellbeing	10 point improvement in Minnesota Living with Heart Failure Questionnaire (MLWHF), 10% improvement of 6 minute walk test(6MWT)	Within 12 month from enrollment