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)
NCT ID: NCT05123430
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-03-23
2022-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MitraClip operated patients suffering from serious mitral insufficiency
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Médipôle Hôpital Privé
Villeurbanne, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Didier CHAMPAGNAC, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A02328-31
Identifier Type: -
Identifier Source: org_study_id