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Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
NCT05298124 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Transcatheter edge-to-edge repair
- OTHER Medical therapy
Study Locations (4)
Ontario
- University of Ottawa Heart Institute — Ottawa
- Sunnybrook Hospital — Toronto
- St. Michael's Hospital — Toronto
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05298124
The ClinicalTrials.gov registry entry for NCT05298124 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ottawa Heart Institute Research Corporation, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 2 interventions — of which Transcatheter edge-to-edge repair is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05298124 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Ontario, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05298124 about?
NCT05298124 is a clinical study titled "Transcatheter Mitral Valve Repair for Inotrope Dependent 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 setti...
What is the current status of trial NCT05298124?
This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2022-05-26. Estimated completion is 2025-12.
What conditions does trial NCT05298124 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Cardiogenic Shock. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05298124?
The interventions under investigation include: Transcatheter edge-to-edge repair (DEVICE), Medical therapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05298124?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05298124 being conducted?
This trial has 4 study locations across Minnesota, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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