Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

NCT ID: NCT05298124

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

Current management strategies for patients with SCAI stage C through E cardiogenic shock include management in a cardiac intensive care unit (CICU) or cardiac surgery intensive care unit (CSICU) with intravenous inotropes (i.e. medications to increase the pumping function of the heart), vasopressors (i.e. medications to increase blood pressure), ventilatory support, and/or mechanical circulatory support. Importantly, with the exception of revascularization, little data exists demonstrating the ability to alter prognosis in patients with cardiogenic shock.

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 divided into two phases, as follows:

Phase 1 (Vanguard) - The first phase of this study will be composed of a feasibility stage where a total of 10 participants from centers in Ontario, Canada will be recruited. The primary objective of this phase is to ascertain feasibility of participant recruitment and treatment. Feasibility would be considered met if 10 participants were enrolled 12 months from the date of activation of all four centers.

Phase 2 - The second phase of this study will be a continuation of Phase 1 where the remaining 134 participants, for a total of 144 participants in the overall study. For this second phase of the study, patients will be recruited from high-volume TEER centers in Canada and the United States - with participating centers performing more than 25 TEER procedures per year.

Eligible participants will be randomly assigned in a 1:1 fashion to the medical therapy arm (i.e. control arm) or the TEER arm (i.e. intervention arm) of the trial.

Conditions

Cardiogenic Shock; Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transcatheter edge-to-edge repair

Intervention Type: DEVICE

Transcatheter edge-to-edge repair

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.

Group Type: ACTIVE_COMPARATOR

Medical therapy

Intervention Type: OTHER

Medical treatment in an intensive care unit

Interventions

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair

Intervention Type: DEVICE

Medical therapy

Medical treatment in an intensive care unit

Intervention Type: OTHER

Other Intervention Names

MitraClip

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Sunnybrook Hospital

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Countries

United States; Canada

Central Contacts

Benjamin Hibbert, MD PhD

Role: CONTACT

bhibbert@ottawaheart.ca

613-696-7115

Pietro Di Santo, MD

Role: CONTACT

pdisanto@ottawaheart.ca

613-696-7000 ext. 15258

Facility Contacts

Benjamin Hibbert, MD PhD

Role: primary

hibbert.benjamin@mayo.edu

Benjamin Hibbert, MD PhD

Role: primary

bhibbert@ottawaheart.ca

613-696-7115

Baylie Morgan, RN

Role: backup

bmorgan@ottawaheart.ca

613-696-7000 ext. 19059

Andrew Czarnecki, MD

Role: primary

andrew.czarnecki@sunnybrook.ca

Neil Fam, MD

Role: primary

neil.fam@unityhealth.to

Other Identifiers

20210381-01T

Identifier Type: -

Identifier Source: org_study_id