Repairing the mitral valve in patients with cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of transcatheter edge-to-edge repair (TEER) in patients experiencing cardiogenic shock with significant mitral regurgitation. It is a multicenter, open-label, randomized-controlled trial comparing TEER to standard medical therapy. Participants will be recruited from intensive care units and will be monitored for improvements in clinical outcomes. The study aims to provide randomized data to support the use of TEER in this critical patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting
• Sunnybrook Hospital
  Toronto, Ontario, Canada Not yet recruiting
• St. Michael's Hospital
  Toronto, Ontario, Canada Not yet recruiting

Study contacts

• Study coordinator: Benjamin Hibbert, MD PhD
• Email: bhibbert@ottawaheart.ca
• Phone: 613-696-7115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.