Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (NCT05298124)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Rochester, Minnesota
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Mayo Clinic — Rochester, Minnesota
- University of Ottawa Heart Institute — Ottawa, Ontario
- Sunnybrook Hospital — Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (613) 696-7115
Email: bhibbert@ottawaheart.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cardiogenic Shock
- A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C — Boston, Massachusetts
- Augmented Pacing for Shock in the Cardiac Intensive Care Unit — Nashville, Tennessee
- Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock — Loma Linda, California
- CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock — Boston, Massachusetts
- Intra-aortic Balloon Counterpulsation (IABC) Compliance — Philadelphia, Pennsylvania
- Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial — Falls Church, Virginia
Explore by condition: All Cardiogenic Shock clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.