Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03431467 · ClinicalTrials.gov registry record · NA
Impella CP With VA ECMO for Cardiogenic Shock
A NA study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03431467: Clinical Trial NA study, sponsored by University of Pennsylvania.
NCT03431467 is a NA study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03431467, a NA study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is indicated as a haemodynamic rescue strategy in decompensated acute or chronic heart failure presenting as cardiogenic shock. It has been used across aeitologies including post-myocardial infarction, dilated cardiomyopathy, acute myocarditis and in post-cardiotomy shock. VA ECMO has a number of effects on the circulation including improved end-organ perfusion and possibly improved coronary perfusion, and is a bridge to further therapies including permanent advanced mechanical circulatory support, cardiac transplantation and to cardiac recovery. Left ventricular assist devices (LVADs) provide long-term mechanical circulatory support and also profoundly mechanically unload the left ventricle. Multiple clinical studies have documented cardiac recovery using LVAD therapy, with a rate between 10-60% in selected populations. A large body of basic science has documented the pivotal role of mechanical load in determining ventricular contractile performance across species. Therefore both clinical data and basic laboratory studies support the notion that profound ventricular unloading may result in improved cardiac performance through a variety of mechanisms ranging from triggered de novo cardiomyocyte proliferation, subcellular calcium handling reverse remodeling, changes to the extracellular matrix of the heart, reverse remodeling of the neurohormal milleu, amongst many others. One of the major deficiencies of peripheral VA-ECMO is its lack of left ventricular unloading, with associated pulmonary congestion, which can derail clinical improvement and hamper cardiac recovery. Indeed, percutaneous VA-ECMO increases LV afterload due to the retrograde blood flow, and because of the lack of venting, there may be progressive LV distension. These conditions can result in a congested, pressure-overloaded ventricle, even in the absence of echocardiographic ventricular distension. This may be ameliorated with the additio
Interventions
- DEVICE Impella-CP LV Vent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03431467
The ClinicalTrials.gov registry entry for NCT03431467 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Impella-CP LV Vent is the first listed.
NCT03431467 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03431467 about?
NCT03431467 is a clinical study titled "Impella CP With VA ECMO for Cardiogenic Shock". Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is indicated as a haemodynamic rescue strategy in decompensated acute or chronic heart failure presenting as cardiogenic shock. It has been used across aeitologies including post-myocardial infarction, dilated cardiomyopathy, acute myocard...
What is the current status of trial NCT03431467?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2018-03-19. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT03431467?
The interventions under investigation include: Impella-CP LV Vent (DEVICE).
Who is sponsoring clinical trial NCT03431467?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.