search
Back to results

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (MINOS)

Primary Purpose

Cardiogenic Shock, Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcatheter edge-to-edge repair
Medical therapy
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcatheter edge-to-edge repair

Medical therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

In hospital all-cause mortality
Death from any cause
In hospital implantation of durable left-ventricular assist device or cardiac transplantation
Implantation of durable left-ventricular assist device or cardiac transplantation
Discharge on inotropes
Discharge from index hospitalization on palliative inotropic therapy
Residual mitral regurgitation
Severity of residual mitral regurgitation as assessed by the core lab on last available in hospital echocardiogram
Technical success
All of the following must be present: I. Absence of procedural mortality II. Successful access, delivery, and retrieval of the device delivery system III. Successful deployment and correct positioning of the first intended device IV. Freedom from emergency surgery or reintervention related to the device or access procedure.
Device success
All of the following must be present: I. Absence of procedural mortality or stroke II. Proper placement and positioning of the device III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure IV. Continued intended safety and performance of the device, including: A. No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Reduction of mitral regurgitation to either optimal or acceptable levels without significant mitral stenosis, and with no greater than mild (1+) paravalvular mitral regurgitation (and without associated hemolysis)
Stroke or transient ischemic attack
Acute episode of a focal or global neurological deficit as determined by or in conjunction with the designated neurologist
Bleeding
Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI) Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in hematocrit Fatal bleeding (bleeding that directly results in death within 7 d)
Vascular access complications
Access site-related arterial or venous injury or injury to surrounding structures
Cardiac structural complications
Cardiac perforation or pseudoaneurysm

Full Information

First Posted
February 11, 2022
Last Updated
October 7, 2022
Sponsor
Ottawa Heart Institute Research Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05298124
Brief Title
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Acronym
MINOS
Official Title
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter edge-to-edge repair
Arm Type
Experimental
Arm Description
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
Arm Title
Medical therapy
Arm Type
Active Comparator
Arm Description
Medical therapy includes treatment in an intensive care unit with intravenous medications (e.g. vasopressors and inotropes), ventilatory support or mechanical circulatory support.
Intervention Type
Device
Intervention Name(s)
Transcatheter edge-to-edge repair
Other Intervention Name(s)
MitraClip
Intervention Description
Transcatheter edge-to-edge repair
Intervention Type
Other
Intervention Name(s)
Medical therapy
Intervention Description
Medical treatment in an intensive care unit
Primary Outcome Measure Information:
Title
Primary composite outcome
Description
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.
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Secondary Outcome Measure Information:
Title
In hospital all-cause mortality
Description
Death from any cause
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
In hospital implantation of durable left-ventricular assist device or cardiac transplantation
Description
Implantation of durable left-ventricular assist device or cardiac transplantation
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Discharge on inotropes
Description
Discharge from index hospitalization on palliative inotropic therapy
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Residual mitral regurgitation
Description
Severity of residual mitral regurgitation as assessed by the core lab on last available in hospital echocardiogram
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Technical success
Description
All of the following must be present: I. Absence of procedural mortality II. Successful access, delivery, and retrieval of the device delivery system III. Successful deployment and correct positioning of the first intended device IV. Freedom from emergency surgery or reintervention related to the device or access procedure.
Time Frame
Measured at exit from procedure room, generally 2 hours after implant
Title
Device success
Description
All of the following must be present: I. Absence of procedural mortality or stroke II. Proper placement and positioning of the device III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure IV. Continued intended safety and performance of the device, including: A. No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Reduction of mitral regurgitation to either optimal or acceptable levels without significant mitral stenosis, and with no greater than mild (1+) paravalvular mitral regurgitation (and without associated hemolysis)
Time Frame
At time of discharge from hospitalization, generally up to 12 weeks following admission
Title
Stroke or transient ischemic attack
Description
Acute episode of a focal or global neurological deficit as determined by or in conjunction with the designated neurologist
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Bleeding
Description
Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI) Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in hematocrit Fatal bleeding (bleeding that directly results in death within 7 d)
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Vascular access complications
Description
Access site-related arterial or venous injury or injury to surrounding structures
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Title
Cardiac structural complications
Description
Cardiac perforation or pseudoaneurysm
Time Frame
Through duration of hospitalization, generally up to 12 weeks following admission
Other Pre-specified Outcome Measures:
Title
All-cause mortality
Description
Death from any cause
Time Frame
6 months
Title
All-cause hospitalization
Description
Hospitalization is defined as admission to an inpatient unit or ward in the hospital for ≥24 h, including an emergency department stay. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition.
Time Frame
6 months
Title
Any re-intervention on the mitral valve
Description
Requiring any transcatheter or surgical re-intervention on the mitral valve
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Hibbert, MD PhD
Phone
613-696-7115
Email
bhibbert@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pietro Di Santo, MD
Phone
613-696-7000
Ext
15258
Email
pdisanto@ottawaheart.ca
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, MD PhD
Phone
613-696-7115
Email
bhibbert@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Hannah Feagan
Phone
613-696-7000
Ext
12678
Email
hfeagan@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The IPD sharing plan is to be decided upon at trial completion.

Learn more about this trial

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

We'll reach out to this number within 24 hrs