RecruitingNot ApplicableNCT05298124

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

144 participants

Start Date

May 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Medical therapy and a medical device called Transcatheter edge-to-edge repair for people with cardiogenic shock and mitral regurgitation. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscatheter edge-to-edge repair

Transcatheter edge-to-edge repair

OTHERMedical therapy

Medical treatment in an intensive care unit


Locations(4)

Mayo Clinic

Rochester, Minnesota, United States

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05298124


Related Trials