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

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01603706

Collaborator

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

172

Enrollment

Locations

Arms

Duration (Months)

19.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Cardiomyopathy	Procedure: Echo guided implantation group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

172 participants

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Demonstrating Percent reduction in left ventricular end systolic (LVESV) at 6 months compared with baseline values. [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 [Within 12 month from enrollment]
A combined clinical event rate - change in NYHA, hospitalization for heart failure, death
Echocardiographic improvement [Within 12 month from enrollment]
>15% improvement in LVESV, >10% improvement in LVEDV, 5% absolute improvement of LVEF
Improvement in wellbeing [Within 12 month from enrollment]
10 point improvement in Minnesota Living with Heart Failure Questionnaire (MLWHF), 10% improvement of 6 minute walk test(6MWT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	Barzilai Medical Center	Ashkelon		Israel
3	Carmel Medical Center	Haifa		Israel
4	Rambam Medical Center	Haifa		Israel
5	Shaare Zedek	Jerusalem		Israel
6	Rabin Medical Center	Petah Tikva		Israel
7	Sheba Medical Center	Ramat Gan		Israel
8	Kaplan Medical Center	Rehovot		Israel
9	Sorasky Medical Center	Tel Aviv		Israel

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