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Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair

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ClinicalTrials.gov Identifier: NCT03993938
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ashwin Vaidyanathan, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE February 17, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
Delta PVI to Delta LAP correlation during MitraClip placement [ Time Frame: Intraprocedure ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Intraprocedure PPV to PVI correlation [ Time Frame: Intraprocedure ]
    Pulse pressure variation (PPV) and simultaneous pleth variability index (PVI) values recorded every 5 minutes after induction of anesthesia during MitraClip procedure are correlated to obtain a Pearson correlation coefficient and p-value
  • Intraprocedure SPV to PVI correlation [ Time Frame: Intraprocedure ]
    Systolic pressure variation (SPV) and simultaneous pleth variability index (PVI) values recorded every 5 minutes after induction of anesthesia during MitraClip procedure are correlated to obtain a Pearson correlation coefficient and p-value
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Official Title  ICMJE Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Mitral Regurgitation
Intervention  ICMJE Device: PVI measurement
Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment
Study Arms  ICMJE Experimental: Patients for TMVR
Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.
Intervention: Device: PVI measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashwin Vaidyanathan, MD 3139539045 avaidya1@hfhs.org
Contact: Trevor J Szymanski, MD 3136224168 tszyman1@hfhs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993938
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ashwin Vaidyanathan, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henry Ford Health System
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP