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The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.
The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive).
Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coriofix treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coriofix System | Device | Treatment of functional mitral regurgitation by reducing the mitral valve annular area through ablation of the posterior annulus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coriofix System Safety | Absence of Major Device- or Procedure-Related Serious Adverse Events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Coriofix System Safety | Absence of Major Device- or Procedure-Related Serious Adverse Events | 6 and 12 months |
| Device technical success | Successful system operation with no related emergency surgery or reintervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boaz Shenhav | Contact | 972-52-561-1151 | boaz.s@bio-refine.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gottsegen National Cardiovascular Center | Recruiting | Budapest | Hungary |
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| Procedure |
| Treatment success | Change of MR grade | 30 days |
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
|
| Institute for Cardiovascular Diseases "Dedinje" | Recruiting | Belgrade | Serbia |
|
| University Clinical Center Kragujevac | Recruiting | Kragujevac | Serbia |
|