Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Cardiospec
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Extracorporeal Shockwave Therapy, Heart Failure, Congestive Heart Failure, Non-invasive, Device Trial, NYHA (New York Heart Association), Ischemic cardiomyopathy, Ischemia, Myocardial contractility
Eligibility Criteria
Inclusion Criteria:
- Patient is male or female 18 years or older.
- Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
- Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
- Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
- Patient is classified as NYHA II to IV.
- Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
- Patients Ejection Fraction < 50%.
- Patient is stable and without clinical events for > 3 months.
- Patient has signed an informed consent form.
- Patient's condition should be stable and should have a life expectancy of >12 months.
- 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:
- Patient with intraventricular thrombus.
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- Patient has active endocarditis, myocarditis or pericarditis.
- 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.
- Patients who are unwilling or unable to cooperate with study procedure.
- Patients who are unwilling to quit smoking during the study procedure (including screening phase).
- Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
- Patient is pregnant.
- Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).
Sites / Locations
- Tel Aviv Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CHF
Arm Description
Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.
Outcomes
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.
An echo examination shall be used to evaluate myocardial contractility post treatments.
Secondary Outcome Measures
6 Minutes Walk Test (6MWT)
Evaluation of 6MWT time from baseline to 6 months post baseline.
Full Information
NCT ID
NCT01251185
First Posted
November 30, 2010
Last Updated
February 17, 2013
Sponsor
Medispec
Collaborators
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01251185
Brief Title
Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
Official Title
Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medispec
Collaborators
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Extracorporeal Shockwave Therapy, Heart Failure, Congestive Heart Failure, Non-invasive, Device Trial, NYHA (New York Heart Association), Ischemic cardiomyopathy, Ischemia, Myocardial contractility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF
Arm Type
Experimental
Arm Description
Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.
Intervention Type
Device
Intervention Name(s)
Cardiospec
Other Intervention Name(s)
Cardiospec ESMR therapy, Extracorporeal Shockwave therapy, Extracorporeal myocardial Revascularization
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
An echo examination shall be used to evaluate myocardial contractility post treatments.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
6 Minutes Walk Test (6MWT)
Description
Evaluation of 6MWT time from baseline to 6 months post baseline.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is male or female 18 years or older.
Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
Patient is classified as NYHA II to IV.
Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
Patients Ejection Fraction < 50%.
Patient is stable and without clinical events for > 3 months.
Patient has signed an informed consent form.
Patient's condition should be stable and should have a life expectancy of >12 months.
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:
Patient with intraventricular thrombus.
Severe COPD (patients with an FEV1 less than .8 liters).
Patient has chronic lung disease including emphysema and pulmonary fibrosis.
Patient has active endocarditis, myocarditis or pericarditis.
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.
Patients who are unwilling or unable to cooperate with study procedure.
Patients who are unwilling to quit smoking during the study procedure (including screening phase).
Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
Patient is pregnant.
Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilton Miller, Professor
Organizational Affiliation
Tel Aviv Souraski Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
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Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
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