Medical therapy: Medical treatment in an intensive care unit
Study 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Participants or substitute decision maker is able and willing to provide written informed consent
2. Age ≥ 18 years
3. 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
4. Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
5. In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve \<3+ MR
Exclusion Criteria:
1. Unwilling or unable to obtain informed consent from the participant or substitute decision maker
2. Revascularization of coronary artery disease performed in the 48 hours prior to randomization
3. If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
4. Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
5. Echocardiographic evidence of left sided intracardiac mass or thrombus
6. Diagnosis of active infective endocarditis
7. Transesophageal echocardiogram is contraindicated
8. Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
9. Any aortic valve disease greater than moderate in severity
10. A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
11. Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
12. Plan for durable mechanical circulatory support implantation prior to TMVr
13. In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
14. Pregnant or planning to become pregnant in the next 6 months.
Primary outcome measure(s)
Primary composite outcome — 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.
Trial sites (4)
Facility
City
Region
Status
Mayo Clinic
Rochester
Minnesota
Recruiting
University of Ottawa Heart Institute
Ottawa
Ontario
Recruiting
Sunnybrook Hospital
Toronto
Ontario
Not Yet Recruiting
St. Michael's Hospital
Toronto
Ontario
Not Yet Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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