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| Name | Class |
|---|---|
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
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Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF | Experimental | Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiospec | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minutes Walk Test (6MWT) | Evaluation of 6MWT time from baseline to 6 months post baseline. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilton Miller, Professor | Tel Aviv Souraski Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |