Clinical trial NCT05123430: Hemodynamic Estimation of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG) (MitraPOG)
Official title: Hemodynamic Estimation Per Procedure of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Insufficiency
Mitraclip
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Médipôle Hôpital Privé
Study officials:
References: