Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Mar 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Transcatheter Edge-to-Edge Repair (TEER) to see if it helps patients who are experiencing severe heart failure (known as cardiogenic shock) and also have a specific heart valve problem called mitral regurgitation. The trial will compare TEER with standard medical treatment to find out which method leads to better outcomes for patients. Researchers want to see if TEER can improve health results for patients who are critically ill and need strong medications or support to help their heart function.

To be eligible for this study, participants must be at least 18 years old and experiencing significant heart issues that require intensive care. They should have moderate to severe mitral regurgitation, meaning their heart valve is not closing properly, which can worsen their condition. Patients will be recruited from specialized heart care units in hospitals. If someone joins the study, they will either receive the TEER procedure or continue with medical therapy, and doctors will monitor their progress closely. It's important to know that this trial is currently recruiting patients and aims to provide valuable information about the best ways to treat these serious heart problems.

Gender

ALL

Eligibility criteria

• 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.