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) (MitraPOG)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Insufficiency; Mitraclip
• Intervention / Treatment: Procedure: Monitoring of the pressure of the middle left atrium

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Recruiting
    • Médipôle Hôpital Privé
    • Contact: Didier CHAMPAGNAC, Dr; Phone Number: 06 82 99 32 64; Email: dchampagnac@cardiopole.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MitraClip operated patients suffering from serious mitral insufficiency	Procedure: Monitoring 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): October 19, 2021
• Study Completion (Anticipated): March 23, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2020-A02328-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No