Repairing the mitral valve in patients with cardiogenic shock
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
This study tests if a new heart procedure called TEER can help patients in cardiogenic shock with leaky mitral valves feel better compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT05298124 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with SCAI stage C or D cardiogenic shock and moderate to severe mitral regurgitation.
Not a fit: Patients who have undergone recent coronary revascularization or have degenerative mitral regurgitation requiring surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve outcomes for patients suffering from cardiogenic shock and severe mitral regurgitation.
How similar studies have performed: While observational studies suggest potential benefits of TEER in similar conditions, this study aims to provide the first randomized clinical data on the subject.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.