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)

Not Applicable

• Conditions: Mitraclip; Mitral Insufficiency
• Interventions: Procedure: Monitoring of the pressure of the middle left atrium

• Registration Number: NCT05123430
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-23
• Primary Completion: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Last Update Submitted: 2021-11-09
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17
• Study Completion: 2022-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MitraClip operated patients suffering from serious mitral insufficiency	Monitoring of the pressure of the middle left atrium	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Médipôle Hôpital Privé; 🇫🇷 Villeurbanne, France