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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)

Primary Purpose

Mitral Insufficiency, Mitraclip

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monitoring of the pressure of the middle left atrium
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mitral Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Médipôle Hôpital PrivéRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MitraClip operated patients suffering from serious mitral insufficiency

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
November 9, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
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1. Study Identification

Unique Protocol Identification Number
NCT05123430
Brief Title
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)
Acronym
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
March 23, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Insufficiency, Mitraclip

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitraClip operated patients suffering from serious mitral insufficiency
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Monitoring of the pressure of the middle left atrium
Intervention Description
During the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium
Primary Outcome Measure Information:
Title
Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Médipôle Hôpital Privé
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier CHAMPAGNAC, Dr
Phone
06 82 99 32 64
Email
dchampagnac@cardiopole.fr

12. IPD Sharing Statement

Learn more about this trial

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)

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