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

October 18, 2017 updated by: Prof. Michael Glikson, Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Sorasky Medical Center
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 12 month from enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Improvement
Time Frame: Within 12 month from enrollment
A combined clinical event rate - change in NYHA, hospitalization for heart failure, death
Within 12 month from enrollment
Echocardiographic improvement
Time Frame: Within 12 month from enrollment
>15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF
Within 12 month from enrollment
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)
Within 12 month from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Mayo Clinic
Rambam Health Care Campus
Rabin Medical Center
Tel-Aviv Sourasky Medical Center
Kaplan Medical Center
Soroka University Medical Center

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 20, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9349-MG-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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