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The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question[s] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.
Participants will be implanted with the Anchord device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anchord Device | Experimental | Anchord device implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anchord device implantation | Device | Anchord Mitral Chordal Repair device implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device or procedure related major adverse events [Safety] | Freedom from device- or procedure-related major adverse events. | 30 days post-procedure. |
| Number of Successful device implantation assessed by imaging [Technical Success] | Successful delivery, deployment, and secure fixation of the device assessed during the procedure. | Day 0 - Procedure day |
| Measure | Description | Time Frame |
|---|---|---|
| MR reduction | Mitral regurgitation reduction of 1 or more degrees | 30 days |
| NYHA class | Improvement in NYHA functional by 1 or more degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaily Shohat | Contact | +972549546605 | shaily.s@life-cord.com |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 90 days post procedure |