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

November 30, 2010
February 17, 2013
January 2011
January 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01251185 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
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
Experimental: CHF
Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.
Intervention: Device: Cardiospec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2012
January 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01251185
ESMR CHF-IL
No
Medispec
Medispec
Tel-Aviv Sourasky Medical Center
Principal Investigator: Hilton Miller, Professor Tel Aviv Souraski Center
Medispec
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP