Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251185
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : February 20, 2013
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):

Brief Summary:
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Cardiospec Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CHF
Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.
Device: Cardiospec
Non-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9).
Other Names:
  • Cardiospec ESMR therapy
  • Extracorporeal Shockwave therapy
  • Extracorporeal myocardial Revascularization

Primary Outcome Measures :
  1. The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography. [ Time Frame: 6 months ]
    An echo examination shall be used to evaluate myocardial contractility post treatments.

Secondary Outcome Measures :
  1. 6 Minutes Walk Test (6MWT) [ Time Frame: 6 months ]
    Evaluation of 6MWT time from baseline to 6 months post baseline.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is male or female 18 years or older.
  2. Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
  3. Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
  4. Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
  5. Patient is classified as NYHA II to IV.
  6. Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
  7. Patients Ejection Fraction < 50%.
  8. Patient is stable and without clinical events for > 3 months.
  9. Patient has signed an informed consent form.
  10. Patient's condition should be stable and should have a life expectancy of >12 months.
  11. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.

Exclusion Criteria:

  1. Patient with intraventricular thrombus.
  2. Severe COPD (patients with an FEV1 less than .8 liters).
  3. Patient has chronic lung disease including emphysema and pulmonary fibrosis.
  4. Patient has active endocarditis, myocarditis or pericarditis.
  5. Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
  6. Patients who are unwilling or unable to cooperate with study procedure.
  7. Patients who are unwilling to quit smoking during the study procedure (including screening phase).
  8. Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
  9. Patient is pregnant.
  10. Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251185

Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Hilton Miller, Professor Tel Aviv Souraski Center

Responsible Party: Medispec Identifier: NCT01251185     History of Changes
Other Study ID Numbers: ESMR CHF-IL
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Medispec:
Extracorporeal Shockwave Therapy
Heart Failure
Congestive Heart Failure
Device Trial
NYHA (New York Heart Association)
Ischemic cardiomyopathy
Myocardial contractility

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases