Actively Recruiting
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-06
144
Participants Needed
4
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or substitute decision maker can provide written informed consent
- Age 18 years or older
- SCAI stage C or D cardiogenic shock with persistent inotrope, vasopressor, non-durable mechanical support, or inability to wean ventilatory support due to pulmonary edema for 24 hours before randomization
- Moderate or greater (3+ or higher) mitral regurgitation confirmed by transesophageal echocardiogram
- Anatomically eligible for transcatheter mitral valve repair with potential to reduce mitral regurgitation to less than 3+ as determined by the study center's heart team
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Coronary artery disease revascularization performed within 48 hours prior to randomization
- Degenerative mitral regurgitation eligible for surgical intervention
- Previous mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
- Presence of left-sided intracardiac mass or thrombus on echocardiogram
- Active infective endocarditis
- Contraindication to transesophageal echocardiogram
- Mitral valve anatomy unsuitable for transcatheter repair as determined by heart team
- Aortic valve disease more than moderate in severity
- Known hypersensitivity or contraindication to procedure medications that cannot be managed medically
- History of cardiac arrest without documented neurological recovery
- Planned durable mechanical circulatory support implantation before transcatheter repair
- Significant comorbidity limiting in-hospital life expectancy as judged by treating team
- Pregnancy or planning pregnancy within next 6 months
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Actively Recruiting
3
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1T8
Not Yet Recruiting
Research Team
B
Benjamin Hibbert, MD PhD
CONTACT
P
Pietro Di Santo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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