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New treatment option for Cardiogenic Shock
Official title Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
ClinicalTrials.gov ID: NCT05298124
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.