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A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revivent TC System | Device | The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous and includes both anterior and septal components. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregg W Stone, MD | Icahn School of Medicine at Mount Sinai, New York, NY | Principal Investigator |
| Jerry Estep, MD | Cleveland Clinic Florida, Weston, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| Penn State Health Milton S. Hershey Medical Center |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hershey |
| Pennsylvania |
| 17033 |
| United States |