Mitral InsufficiencyMitraPOGNCT05123430
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)
A study testing Monitoring of the pressure of the middle left atrium in people with Mitral Insufficiency and Mitraclip, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Insufficiency, Mitraclip
- What is being tested?
- Monitoring of the pressure of the middle left atrium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2021to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Médipôle Hôpital Privé
Villeurbanne, 69100
Didier CHAMPAGNAC, Dr, 06 82 99 32 64, dchampagnac@cardiopole.fr
About this study
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)
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
- Being tested
- Monitoring of the pressure of the middle left atrium
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of the pressure of the middle left atriumProcedure or surgery
During the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium
| Study group | Role | What they receive |
|---|---|---|
| MitraClip operated patients suffering from serious mitral insufficiency | Experimental | Not described Receives: Procedure: Monitoring of the pressure of the middle left atrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start23 Mar 2021
- Primary completion19 Oct 2021
- Study completion23 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123430
- Sponsor's protocol ID
- 2020-A02328-31
- Acronym
- MitraPOG
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05123430
- Acronym / sponsor ID
- MitraPOG / 2020-A02328-31
- Conditions
- Mitral Insufficiency, Mitraclip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 23 Mar 2022 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip operated patients suffering from serious mitral insufficiency | Experimental | Procedure: Monitoring of the pressure of the middle left atrium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Woman or man over 18 years old
- Patient with symptomatic mitral leakage (grade 3+ or 4+) at high surgical risk defined as:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of the pressure of the middle left atriumDuring the MitraClip surgery, additional catheter is installed in order to monitoring the ppressure of the middle left atrium | Procedure or surgery | MitraClip operated patients suffering from serious mitral insufficiency |
Primary outcome
Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of the pressure of the middle left atrium in people with Mitral Insufficiency and Mitraclip, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.