NCT05298124

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2022May 2028

First Submitted

Initial submission to the registry

February 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

February 11, 2022

Last Update Submit

April 29, 2026

Conditions

Cardiogenic ShockMitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Primary composite outcome

    The primary outcome in this clinical trial will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable LVAD, or discharge on palliative inotropic therapy.

    Through duration of hospitalization, generally up to 12 weeks following admission

Secondary Outcomes (10)

  • In hospital all-cause mortality

    Through duration of hospitalization, generally up to 12 weeks following admission

  • In hospital implantation of durable left-ventricular assist device or cardiac transplantation

    Through duration of hospitalization, generally up to 12 weeks following admission

  • Discharge on inotropes

    Through duration of hospitalization, generally up to 12 weeks following admission

  • Residual mitral regurgitation

    Through duration of hospitalization, generally up to 12 weeks following admission

  • Technical success

    Measured at exit from procedure room, generally 2 hours after implant

  • +5 more secondary outcomes

Other Outcomes (3)

  • All-cause mortality

    6 months

  • All-cause hospitalization

    6 months

  • Any re-intervention on the mitral valve

    6 months

Study Arms (2)

Transcatheter edge-to-edge repair

EXPERIMENTAL

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

Device: Transcatheter edge-to-edge repair

Medical therapy

ACTIVE COMPARATOR

Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support.

Other: Medical therapy

Interventions

Transcatheter edge-to-edge repairDEVICE

Transcatheter edge-to-edge repair

Also known as: MitraClip
Transcatheter edge-to-edge repair
Medical therapyOTHER

Medical treatment in an intensive care unit

Medical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to obtain informed consent from the participant or substitute decision maker
  • Revascularization of coronary artery disease performed in the 48 hours prior to randomization
  • If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
  • Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
  • Echocardiographic evidence of left sided intracardiac mass or thrombus
  • Diagnosis of active infective endocarditis
  • Transesophageal echocardiogram is contraindicated
  • Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
  • Any aortic valve disease greater than moderate in severity
  • A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
  • Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
  • Plan for durable mechanical circulatory support implantation prior to TMVr
  • In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
  • Pregnant or planning to become pregnant in the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1T8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicMitral Valve Insufficiency

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Benjamin Hibbert, MD PhD

CONTACT

613-696-7115bhibbert@ottawaheart.ca

Pietro Di Santo, MD

CONTACT

613-696-7000pdisanto@ottawaheart.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 28, 2022

Study Start

May 26, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

CA(3)US(1)