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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Sheba Medical Center
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01603706
First received: May 14, 2012
Last updated: October 24, 2013
Last verified: October 2013
  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
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

Resource links provided by NLM:


Further study details as provided by 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. ] [ 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 212
Study Start Date: May 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: May 14, 2012
Last Updated: October 24, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014