NCT05298124Recruiting
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 11 Feb 2022
- Start date
- 26 May 2022
- Primary completion date
- May 2028
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- NCT number
- NCT05298124
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 26 May 2022 to the primary completion date, May 2028
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Revascularization of coronary artery disease performed in the 48 hours prior to randomization
- Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
- Plan for durable mechanical circulatory support implantation prior to TMVr
Other illness
- If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
- 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
Other
- Unwilling or unable to obtain informed consent from the participant or substitute decision maker
- Echocardiographic evidence of left sided intracardiac mass or thrombus
- Diagnosis of active infective endocarditis
- Transesophageal echocardiogram is contraindicated
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Sunnybrook Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.