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Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vslingâ„¢ 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 device | 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 Vslingâ„¢ implantation procedure or the Vslingâ„¢ device | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Yadin-Herling | Contact | 972546633352 | iris.yh@cardiacsuccess.com |
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