RECRUITING

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Quick Facts

Study Start:2022-05-26
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05298124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants or substitute decision maker is able and willing to provide written informed consent
  2. 2. Age ≥ 18 years
  3. 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. 4. Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
  5. 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
  1. 1. Unwilling or unable to obtain informed consent from the participant or substitute decision maker
  2. 2. Revascularization of coronary artery disease performed in the 48 hours prior to randomization
  3. 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. 4. Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
  5. 5. Echocardiographic evidence of left sided intracardiac mass or thrombus
  6. 6. Diagnosis of active infective endocarditis
  7. 7. Transesophageal echocardiogram is contraindicated
  8. 8. Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
  9. 9. Any aortic valve disease greater than moderate in severity
  10. 10. A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
  11. 11. Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
  12. 12. Plan for durable mechanical circulatory support implantation prior to TMVr
  13. 13. In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
  14. 14. Pregnant or planning to become pregnant in the next 6 months.

Contacts and Locations

Study Contact

Benjamin Hibbert, MD PhD
CONTACT
613-696-7115
bhibbert@ottawaheart.ca
Pietro Di Santo, MD
CONTACT
613-696-7000
pdisanto@ottawaheart.ca

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-26
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-05-26
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiogenic Shock
  • Mitral Regurgitation