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NCT03993938 · ClinicalTrials.gov registry record · NA
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
A NA study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03993938 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 30 participants.
The verdict
NCT03993938, a NA study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk. Successful MitraClip application depends on intraprocedural quantification of mitral regurgitation and left atrial pressure (LAP) monitoring. The pleth variability index (PVI) is a noninvasive, dynamic index based on analysis of the respiratory variations in the plethysmographic waveform recorded transcutaneously by the pulse oximeter. Studies demonstrate that PVI is accurate in predicting fluid responsiveness in mechanically ventilated adult patients. In this study, we wish to measure PVI during TMVR and correlate with invasive indices such as left atrial pressure (LAP) and stroke volume variation. Our study hopes to provide a real-time non-invasive alternative to invasive indices to better guide fluid management and improve hemodynamics.
Interventions
- DEVICE PVI measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2021-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03993938
The ClinicalTrials.gov registry entry for NCT03993938 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PVI measurement is the first listed.
NCT03993938 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03993938 about?
NCT03993938 is a clinical study titled "Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair". Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk. Successful MitraClip application depends on intraprocedural quantification of mitral regurgitation...
What is the current status of trial NCT03993938?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-10-01. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03993938?
The interventions under investigation include: PVI measurement (DEVICE).
Who is sponsoring clinical trial NCT03993938?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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