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

NCT ID: NCT01251185

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHF

Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology.

Group Type: EXPERIMENTAL

Cardiospec

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Cardiospec ESMR therapy; Extracorporeal Shockwave therapy; Extracorporeal myocardial Revascularization

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: collaborator

Medispec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilton Miller, Professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Souraski Center

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

ESMR CHF-IL

Identifier Type: -

Identifier Source: org_study_id