Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants or substitute decision maker is able and willing to provide written informed consent

• Age ≥ 18 years

• 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

• Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)

• In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve \<3+ MR

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
Sunnybrook Hospital
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Benjamin Hibbert, MD PhD
bhibbert@ottawaheart.ca
613-696-7115
Backup
Pietro Di Santo, MD
pdisanto@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 144
Treatments
Experimental: Transcatheter edge-to-edge repair
The experimental arm includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support plus transcatheter edge-to-edge repair
Active_comparator: Medical therapy
Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support.
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov