Cardiogenic ShockMINOSNCT05298124
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
A study testing Transcatheter edge-to-edge repair and Medical therapy in people with Cardiogenic Shock and Mitral Regurgitation, run by Ottawa Heart Institute Research Corporation at 4 sites in 2 countries.
Trial summary
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Mitral Regurgitation
- What is being tested?
- Transcatheter edge-to-edge repair and Medical therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 May 2022to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants or substitute decision maker is able and willing to provide written informed consent
- Age ≥ 18 years
- SCAI stage C or D cardiogenic shock with persistent inotrope/vasopressor/non-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization
- Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
- In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve <3+ MR
Who cannot join
- Unwilling or unable to obtain informed consent from the participant or substitute decision maker
- Revascularization of coronary artery disease performed in the 48 hours prior to randomization
- If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
- Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
- Echocardiographic evidence of left sided intracardiac mass or thrombus
- Diagnosis of active infective endocarditis
Show all 14Show fewer
- Transesophageal echocardiogram is contraindicated
- Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
- Any aortic valve disease greater than moderate in severity
- A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
- Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
- Plan for durable mechanical circulatory support implantation prior to TMVr
- In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
- Pregnant or planning to become pregnant in the next 6 months.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Canada3 sites, 3 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
Benjamin Hibbert, MD PhD, 613-696-7115, bhibbert@ottawaheart.ca
Baylie Morgan, RN, 613-696-7000 ext. 19059, bmorgan@ottawaheart.ca
- Not yet recruiting
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Andrew Czarnecki, MD, andrew.czarnecki@sunnybrook.ca
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1T8
Neil Fam, MD, neil.fam@unityhealth.to
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Benjamin Hibbert, MD PhD, hibbert.benjamin@mayo.edu
About this study
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.
This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited.
Read more
The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?"
The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.
Read the detailed description
Current management strategies for patients with SCAI stage C through E cardiogenic shock include management in a cardiac intensive care unit (CICU) or cardiac surgery intensive care unit (CSICU) with intravenous inotropes (i.e. medications to increase the pumping function of the heart), vasopressors (i.e. medications to increase blood pressure), ventilatory support, and/or mechanical circulatory support. Importantly, with the exception of revascularization, little data exists demonstrating the ability to alter prognosis in patients with cardiogenic shock.
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.
This study will be divided into two phases, as follows:
Phase 1 (Vanguard) - The first phase of this study will be composed of a feasibility stage where a total of 10 participants from centers in Ontario, Canada will be recruited. The primary objective of this phase is to ascertain feasibility of participant recruitment and treatment. Feasibility would be considered met if 10 participants were enrolled 12 months from the date of activation of all four centers.
Phase 2 - The second phase of this study will be a continuation of Phase 1 where the remaining 134 participants, for a total of 144 participants in the overall study. For this second phase of the study, patients will be recruited from high-volume TEER centers in Canada and the United States - with participating centers performing more than 25 TEER procedures per year.
Eligible participants will be randomly assigned in a 1:1 fashion to the medical therapy arm (i.e. control arm) or the TEER arm (i.e. intervention arm) of the trial.
- Conditions
- Cardiogenic Shock, Mitral Regurgitation
- Being tested
- Transcatheter edge-to-edge repair, Medical therapy
- Medical subject headings
- Shock, Cardiogenic, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter edge-to-edge repairDevice
Also called MitraClip
Transcatheter edge-to-edge repair
Medical therapyOther
Medical treatment in an intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter edge-to-edge repair | Experimental | The experimental arm includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support plus transcatheter edge-to-edge repair Receives: Device: Transcatheter edge-to-edge repair |
| Medical therapy | Active comparator | Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support. Receives: Other: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite outcome
The primary outcome in this clinical trial will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable LVAD, or discharge on palliative inotropic therapy.
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Secondary outcomes (10)
In hospital all-cause mortality
Death from any cause
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
In hospital implantation of durable left-ventricular assist device or cardiac transplantation
Implantation of durable left-ventricular assist device or cardiac transplantation
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Discharge on inotropes
Discharge from index hospitalization on palliative inotropic therapy
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Residual mitral regurgitation
Severity of residual mitral regurgitation as assessed by the core lab on last available in hospital echocardiogram
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Technical success
All of the following must be present:
- Absence of procedural mortality II. Successful access, delivery, and retrieval of the device delivery system III. Successful deployment and correct positioning of the first intended device IV. Freedom from emergency surgery or reintervention related to the device or access procedure.
Measured: Measured at exit from procedure room, generally 2 hours after implant
Device success
All of the following must be present:
- Absence of procedural mortality or stroke II. Proper placement and positioning of the device III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure
IV. Continued intended safety and performance of the device, including:
- No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Reduction of mitral regurgitation to either optimal or acceptable levels without significant mitral stenosis, and with no greater than mild (1+) paravalvular mitral regurgitation (and without associated hemolysis)
Measured: At time of discharge from hospitalization, generally up to 12 weeks following admission
Stroke or transient ischemic attack
Acute episode of a focal or global neurological deficit as determined by or in conjunction with the designated neurologist
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Bleeding
- Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI)
- Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in hematocrit
- Fatal bleeding (bleeding that directly results in death within 7 d)
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Vascular access complications
Access site-related arterial or venous injury or injury to surrounding structures
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Cardiac structural complications
Cardiac perforation or pseudoaneurysm
Measured: Through duration of hospitalization, generally up to 12 weeks following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start26 May 2022
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298124
- Sponsor's protocol ID
- 20210381-01T
- Acronym
- MINOS
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan is to be decided upon at trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT05298124
- Acronym / sponsor ID
- MINOS / 20210381-01T
- Conditions
- Cardiogenic Shock, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Mar 2022 (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.
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.
This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited.
The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?"
The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.
Detailed description
Current management strategies for patients with SCAI stage C through E cardiogenic shock include management in a cardiac intensive care unit (CICU) or cardiac surgery intensive care unit (CSICU) with intravenous inotropes (i.e. medications to increase the pumping function of the heart), vasopressors (i.e. medications to increase blood pressure), ventilatory support, and/or mechanical circulatory support. Importantly, with the exception of revascularization, little data exists demonstrating the ability to alter prognosis in patients with cardiogenic shock.
Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.
This study will be divided into two phases, as follows:
Phase 1 (Vanguard) - The first phase of this study will be composed of a feasibility stage where a total of 10 participants from centers in Ontario, Canada will be recruited. The primary objective of this phase is to ascertain feasibility of participant recruitment and treatment. Feasibility would be considered met if 10 participants were enrolled 12 months from the date of activation of all four centers.
Phase 2 - The second phase of this study will be a continuation of Phase 1 where the remaining 134 participants, for a total of 144 participants in the overall study. For this second phase of the study, patients will be recruited from high-volume TEER centers in Canada and the United States - with participating centers performing more than 25 TEER procedures per year.
Eligible participants will be randomly assigned in a 1:1 fashion to the medical therapy arm (i.e. control arm) or the TEER arm (i.e. intervention arm) of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter edge-to-edge repair | Experimental | Device: Transcatheter edge-to-edge repairThe experimental arm includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support plus transcatheter edge-to-edge repair |
| Medical therapy | Active comparator | Other: Medical therapyMedical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants or substitute decision maker is able and willing to provide written informed consent
- Age ≥ 18 years
- SCAI stage C or D cardiogenic shock with persistent inotrope/vasopressor/non-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization
- Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
- In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve <3+ MR
Key exclusion criteria (14 listed)
- Unwilling or unable to obtain informed consent from the participant or substitute decision maker
- Revascularization of coronary artery disease performed in the 48 hours prior to randomization
- If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
- Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
- Echocardiographic evidence of left sided intracardiac mass or thrombus
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 |
|---|---|---|
| Transcatheter edge-to-edge repairAlso: MitraClipTranscatheter edge-to-edge repair | Device | Transcatheter edge-to-edge repair |
| Medical therapyMedical treatment in an intensive care unit | Other | Medical therapy |
Primary outcome
Primary composite outcome
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
The primary outcome in this clinical trial will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable LVAD, or discharge on palliative inotropic therapy.
10 secondary outcomes
In hospital all-cause mortality
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
In hospital implantation of durable left-ventricular assist device or cardiac transplantation
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Discharge on inotropes
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Residual mitral regurgitation
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Technical success
Time frame: Measured at exit from procedure room, generally 2 hours after implant
Device success
Time frame: At time of discharge from hospitalization, generally up to 12 weeks following admission
Stroke or transient ischemic attack
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Bleeding
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Vascular access complications
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Cardiac structural complications
Time frame: Through duration of hospitalization, generally up to 12 weeks following admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan is to be decided upon at trial completion.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter edge-to-edge repair and Medical therapy in people with Cardiogenic Shock and Mitral Regurgitation, run by Ottawa Heart Institute Research Corporation at 4 sites in 2 countries.
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Hibbert, MD PhD (613-696-7115, bhibbert@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary composite outcome (time frame: Through duration of hospitalization, generally up to 12 weeks following admission). 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 6 May 2026.