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Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vsling | Experimental | Vsling Device implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vsling | Device | Implantable ventricular repair device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device related Serious Adverse Events (SAE) | Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tami Abudi, +972 | Contact | +972 (52) 5989833 | tami.a@cardiacsuccess.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Not yet recruiting | Be’er Ya‘aqov | Israel |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Rambam Medical Center | Recruiting | Haifa | Israel |
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| Hadassah Medical Center | Not yet recruiting | Jerusalem | Israel |
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| Rabin Medical Center | Not yet recruiting | Petah Tikva | Israel |
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| Tzafon Medical Center | Recruiting | Poria – Neve Oved | Israel |
|