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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: Completed NA study, sponsored by Henry Ford Health System.
NCT03993938 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Delta pleth variability index (PVI) and delta left atrial pressure (LAP) are calculated by subtracting the values of LAP (as obtained intraprocedurally) and corresponding PVI value (as recorded by the Masimo Radical-7 probe) from the LAP and PVI value respectively after MitraClip placement. The delta PVI and delta LAP for the sample patient population are correlated to obtain the Pearson correlation coefficient and p-value
Interventions
- DEVICE PVI measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2021-06-01 |
| Phase | NA |
What the finished NCT03993938 record still lists
NCT03993938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which PVI measurement is the first listed.
NCT03993938 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03993938's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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