Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Transcatheter edge-to-edge repair
DeviceTranscatheter edge-to-edge repair
Medical therapy
Other interventionMedical treatment in an intensive care unit
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Transcatheter edge-to-edge repairExperimental treatment 1 intervention
Group B: Medical therapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Through duration of hospitalization, generally up to 12 weeks following admissionSecondary outcomes
1
In hospital all-cause mortality
Death from any cause
Time frame
Through duration of hospitalization, generally up to 12 weeks following admission2
In hospital implantation of durable left-ventricular assist device or cardiac transplantation
Implantation of durable left-ventricular assist device or cardiac transplantation
Time frame
Through duration of hospitalization, generally up to 12 weeks following admission3
Discharge on inotropes
Discharge from index hospitalization on palliative inotropic therapy
Time frame
Through duration of hospitalization, generally up to 12 weeks following admission4
Residual mitral regurgitation
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 admissionOther outcomes
1
All-cause mortality
Death from any cause
Time frame
6 months2
All-cause hospitalization
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 months3
Any re-intervention on the mitral valve
Requiring any transcatheter or surgical re-intervention on the mitral valve
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov