N/A
N=30
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Mitral Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT03993938 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Delta PVI to Delta LAP Correlation During MitraClip Placement — 4.30; -26.14 percentage of baseline (pre-MitraClip) — p=0.066
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PVI measurement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delta PVI to Delta LAP Correlation During MitraClip Placement |
4.30; -26.14 | 0.066 |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female patients with mitral regurgitation undergoing transcatheter mitral valve repair(TMVR) with Mitra-Clip(R) at Henry Ford Hospital - Main Campus.
Exclusion Criteria
- MitraClip(R) procedure unsuccessful (defined as no clip deployment and/or procedural interruption due to complication), concomitant aortic regurgitation or stenosis of moderate or greater degree existed, patients with grade II or above diastolic dysfunction on echocardiography, previous mitral valve intervention (either surgical or percutaneous), patients requiring continuous vasopressor infusions during the procedure, or patients in whom PVI monitoring was not performed due to technical issues, patients with atrial fibrillation, or preprocedure moderate or greater mitral stenosis
Data sourced from ClinicalTrials.gov (NCT03993938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.