Mitraclip, Mitral Insufficiency
Conditions
Brief summary
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.
Interventions
PROCEDUREMonitoring of the pressure of the middle left atrium
During the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium
Sponsors
European Clinical Trial Experts Network
Ramsay Générale de Santé
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman or man over 18 years old * Patient with symptomatic mitral leakage (grade 3+ or 4+) at high surgical risk defined as: * Age ≥ 75 years and an STS score ≥ 6%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix. * Age \<75 years and an STS score\> 8%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix. * Patient rejected for surgery. * 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
* Patient with unfavorable ultrasound parameters (for example: patient with insufficient mitral surface). * Patient with recent or active infection. * Patient with a contraindication to the transseptal puncture. * Patient with valve anatomy incompatible with the placement of the device. * Patient with an anomaly of the tricuspid valve justifying a surgical intervention. * Patient who has had a percutaneous cardiovascular procedure within the previous 30 days. * Patient who had heart surgery in the previous 30 days. * Patient with a history of surgery on the mitral valve. * Patient having had a stroke in the previous 30 days. * Patient participating in another clinical study. * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. * Pregnant, breastfeeding or parturient woman. * Patient hospitalized without consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure. | 6 months | 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. |
Countries
France
Contacts
Primary ContactJean-François Oudet
Backup ContactMarie-Hélène Barba
Outcome results
None listed