Recruiting

Transcatheter Mitral Valve Repair

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT05298124

Conditions

Cardiogenic Shock

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter edge-to-edge repair

Medical therapy

Study Details

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.

Conditions

Cardiogenic Shock

Mitral Regurgitation

Study ID

NCT05298124

Start date

May 26, 2022

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair

Medical therapy

Medical treatment in an intensive care unit

Primary outcome measure

  • Primary composite outcome [ Time Frame: Through duration of hospitalization, generally up to 12 weeks following admission ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Benjamin Hibbert, MD PhD

hibbert.benjamin@mayo.edu

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y4W7

Contacts

Principal Investigator:

Rebecca Mathew, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-06.