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| Name | Class |
|---|---|
| European Clinical Trial Experts Network | OTHER |
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this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound.
The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip operated patients suffering from serious mitral insufficiency | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring of the pressure of the middle left atrium | Procedure | During the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure. | The percentage of improvement is defined by the value (B-A) / A * 100, with A = mean arterial pressure / mean left atrium pressure ratio at the start of the procedure and B = mean left atrium pressure / mean arterial pressure ratio at the end of the procedure. | 6 months |
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Inclusion Criteria:
Woman or man over 18 years old
Patient with symptomatic mitral leakage (grade 3+ or 4+) at high surgical risk defined as:
Patient with a life expectancy of over 1 year.
Patient affiliated or beneficiary of a social security scheme.
Patient having been informed and having signed a written consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François Oudet | Contact | 0683346567 | jf.oudet@ecten.eu | |
| Marie-Hélène Barba | Contact | mh.barba@ecten.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Médipôle Hôpital Privé | Recruiting | Villeurbanne | 69100 | France |
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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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