Clinical trial 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
- The study wants to see if a transcatheter edge‑to‑edge repair (TEER) improves outcomes compared with standard medical care in patients with cardiogenic shock and moderate or worse mitral regurgitation.
- Who it's for
- Adults in the ICU with SCAI stage C or D cardiogenic shock and a moderate or greater leaking mitral valve.
- What's involved
- Participants will either receive usual medical treatment or undergo the TEER procedure, which clips the valve together through a catheter. They will have follow‑up visits and tests to monitor heart function.
- Time commitment
- The trial lasts until the study’s primary outcome is reached, with several hospital visits and follow‑up appointments over the course of the study.
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 is enrolling
- Rochester, Minnesota, United States
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Rochester, Minnesota, United States; Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.