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

This study has been completed.
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Medispec
ClinicalTrials.gov Identifier:
NCT01251185
First received: November 30, 2010
Last updated: February 17, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
 Device: Cardiospec
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Medispec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    An echo examination shall be used to evaluate myocardial contractility post treatments.


Secondary Outcome Measures:
  • 6 Minutes Walk Test (6MWT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of 6MWT time from baseline to 6 months post baseline.


Enrollment: 9
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251185

Locations
Israel
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Medispec
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Hilton Miller, Professor Tel Aviv Souraski Center
  More Information

No publications provided

Responsible Party: Medispec
ClinicalTrials.gov Identifier: NCT01251185     History of Changes
Other Study ID Numbers: ESMR CHF-IL
Study First Received: November 30, 2010
Last Updated: February 17, 2013
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013