Radial Strain ECHO-Guided Implantation of Cardiac Resynchronization Therapy (RAISE-CRT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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|
- Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values. [ Time Frame: within 12 month from enrollment. ] [ Designated as safety issue: No ]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.
- Clinical Improvement [ Time Frame: Within 12 month from enrollment ] [ Designated as safety issue: No ]A combined clinical event rate - change in NYHA, hospitalization for heart failure, death
- Echocardiographic improvement [ Time Frame: Within 12 month from enrollment ] [ Designated as safety issue: No ]>15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF
- Improvement in wellbeing [ Time Frame: Within 12 month from enrollment ] [ Designated as safety issue: No ]10 point improvement in Minnesota Living with Heart Failure Questionnaire (MLWHF), 10% improvement of 6 minute walk test(6MWT)
|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)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603706
|Contact: Michael Glikson, MDfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Paul Friedman, MD 507-284-2511 email@example.com|
|Principal Investigator: Paul Friedman, MD|
|Barzilai Medical Center||Recruiting|
|Contact: Orna Tubul firstname.lastname@example.org|
|Principal Investigator: Vladimir Halamazer, MD|
|Carmel Medical Center||Not yet recruiting|
|Contact: Mali Aizenhook MaliAz@clalit.org.il|
|Principal Investigator: Arie Militiano, MD|
|Rambam Medical Center||Recruiting|
|Contact: Monther Boulos, MD 972-4-8543474 email@example.com|
|Principal Investigator: Monther Boulos, MD|
|Contact: Astrid firstname.lastname@example.org|
|Principal Investigator: Aharon Medina, MD|
|Rabin Medical Center||Recruiting|
|Petah Tikva, Israel|
|Contact: Gregory Golovchiner, MD 972-3-9377108 email@example.com|
|Principal Investigator: Gregory Golovchiner, MD|
|Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Contact: Michael Glikson, MD 972-3-5302608 firstname.lastname@example.org|
|Principal Investigator: Michael Glikson, MD|
|Kaplan Medical Center||Recruiting|
|Contact: Moshe Swissa, MD 972-8-9441883 email@example.com|
|Principal Investigator: Dr. Moshe Swissa, MD|
|Sorasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Sami Viskin, MD 972-3-6973311 firstname.lastname@example.org|
|Principal Investigator: Sami Viskin, MD|
|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|