Mitral Regurgitation FunctionalMSSNCT04399499
Percutaneous Mitral Valve Repair in Cardiogenic Shock: Mitra-Shock Study
An observational study of Mitral Regurgitation Functional, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation Functional
- What is being tested?
- MitraClip implantation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2020to Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CS and concomitant severe MR who underwent PMVR between 01/01/2012 to 01/01/2020 will be included in the study. Five Italian centers with high volume of MitraClip procedures will participate in the study. The number of enrolled patients will be of 30 patients. All patients will be older than 18 years old. Patients enrolled at our center (OSR) will be of 10 patients. The patients can tolerate antiplatelets and anticoagulant therapy. Inclusion criteria are: cardiogenic shock, severe mitral regurgitation, prohibitive surgical risk (STS>10%), anatomic feasibility of PMVR with MitraClip® system. Exclusion criteria are: multiorgan failure, VA-ECMO, inadequate peripheral access because of vascular disease, not suitable mitral valve anatomy.
Who may be able to join
- older than 18 years old
Who cannot join
- multiorgan failure,
- VA-ECMO,
- inadequate peripheral access because of vascular disease,
- not suitable mitral valve anatomy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCSS San Raffaele
Milan
Eustachio Agricola, Professor, 3386314591, agricola.eustachio@hsr.it
About this study
Official title: Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).
Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).
It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020
- Conditions
- Mitral Regurgitation Functional
- Being tested
- MitraClip implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip implantationDevice
The MitraClip® procedure is performed under general anesthesia and orotracheal intubation. The procedure is usually guided by 2 and 3-dimensional transesophageal echocardiography and fluoroscopy. This catheter-based technology is inserted through femoral venous access and advanced in the left atrium through the transseptal puncture. The MitraClip® is provided by 2 arms able to grasp the anterior and posterior mitral leaflets. The goal is to approximate both leaflets creating a double orifice mitral valve mimicking the edge-to-edge surgical repair procedure (Alfieri stitch).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Mortality
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 posted22 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation FunctionalStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agricola Eustachio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399499
- Sponsor's protocol ID
- MITRA-SHOCK-2020
- Acronym
- MSS
- Status last verified
- Jun 2020
- First submitted
- 18 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).
- ClinicalTrials.gov ID
- NCT04399499
- Acronym / sponsor ID
- MSS / MITRA-SHOCK-2020
- Conditions
- Mitral Regurgitation Functional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 May 2020 (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.
Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).
It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CS and concomitant severe MR who underwent PMVR between 01/01/2012 to 01/01/2020 will be included in the study. Five Italian centers with high volume of MitraClip procedures will participate in the study. The number of enrolled patients will be of 30 patients. All patients will be older than 18 years old. Patients enrolled at our center (OSR) will be of 10 patients. The patients can tolerate antiplatelets and anticoagulant therapy. Inclusion criteria are: cardiogenic shock, severe mitral regurgitation, prohibitive surgical risk (STS>10%), anatomic feasibility of PMVR with MitraClip® system. Exclusion criteria are: multiorgan failure, VA-ECMO, inadequate peripheral access because of vascular disease, not suitable mitral valve anatomy.
Key inclusion criteria (1 listed)
- older than 18 years old
Key exclusion criteria (4 listed)
- multiorgan failure,
- VA-ECMO,
- inadequate peripheral access because of vascular disease,
- not suitable mitral valve anatomy.
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 |
|---|---|---|
| MitraClip implantationThe MitraClip® procedure is performed under general anesthesia and orotracheal intubation. The procedure is usually guided by 2 and 3-dimensional transesophageal echocardiography and fluoroscopy. This catheter-based technology is inserted through femoral venous access and advanced in the left atrium through the transseptal puncture. The MitraClip® is provided by 2 arms able to grasp the anterior and posterior mitral leaflets. The goal is to approximate both leaflets creating a double orifice mitral valve mimicking the edge-to-edge surgical repair procedure (Alfieri stitch). | Device | – |
Primary outcome
Mortality
Time frame: 30 days
Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation Functional, run by IRCCS San Raffaele at 1 site in Italy.
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 1 inclusion and 4 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 9 Jun 2020. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 9 Jun 2020.