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)

NCT05123430 | Unknown

• 1 other identifier: 2020-A02328-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Insufficiency; Mitraclip

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MitraClip operated patients suffering from serious mitral insufficiency

EXPERIMENTAL

Procedure: Monitoring of the pressure of the middle left atrium

Interventions

Monitoring of the pressure of the middle left atrium PROCEDURE

During the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium

MitraClip operated patients suffering from serious mitral insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Médipôle Hôpital Privé

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 17, 2021
• Study Start: March 23, 2021
• Primary Completion: October 19, 2021
• Study Completion: March 23, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

FR (1)