Clinical trial NCT01251185: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2010-12-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: 6 Minutes Walk Test (6MWT)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Souraski Center
name: Hilton Miller, Professor
role: PRINCIPAL_INVESTIGATOR
References: