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NCT05298124 · ClinicalTrials.gov registry record · NA
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
A NA study of Mitral Regurgitation and Cardiogenic Shock, sponsored by Ottawa Heart Institute Research Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 4
- Study locations
NCT05298124 is a NA study of Mitral Regurgitation and Cardiogenic Shock that is actively recruiting participants, run by Ottawa Heart Institute Research Corporation. The registered enrollment target is 144 participants, below the 1,019-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (86% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT05298124, a NA study of Mitral Regurgitation and Cardiogenic Shock, is actively recruiting participants, sponsored by Ottawa Heart Institute Research Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,019-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (86% lower). The listed sponsor is Ottawa Heart Institute Research Corporation, which has 10 total studies on file at ClinicalTrials.gov.
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.
NCT05298124 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Ontario, Minnesota.
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.
What interventions are being tested in trial NCT05298124?
The interventions under investigation include: Transcatheter edge-to-edge repair (DEVICE), Medical therapy (OTHER).
Who is sponsoring clinical trial NCT05298124?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
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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