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)

Ramsay Générale de Santé

Status

Unknown

Conditions

Mitral Insufficiency

Mitraclip

Treatments

Procedure: Monitoring of the pressure of the middle left atrium

Study type

Interventional

Funder types

Other

Identifiers

NCT05123430

2020-A02328-31

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.