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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

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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: PVI measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Patients for TMVR
Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993938


Contacts
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Contact: Ashwin Vaidyanathan, MD 3139539045 avaidya1@hfhs.org
Contact: Trevor J Szymanski, MD 3136224168 tszyman1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Ashwin Vaidyanathan, Principal Investigator, Resident, Department of Anesthesiology, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03993938     History of Changes
Other Study ID Numbers: 1
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ashwin Vaidyanathan, Henry Ford Health System:
transcatheter mitral valve repair
pleth variability index
Mitraclip
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases