免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Study Description
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 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | May 1, 2021 |
| Estimated Study Completion Date : | July 1, 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Ashwin Vaidyanathan, MD | 3139539045 | avaidya1@hfhs.org | |
| Contact: Trevor J Szymanski, MD | 3136224168 | tszyman1@hfhs.org |
Locations
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
Sponsors and Collaborators
Henry Ford Health System
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 17, 2019 | ||||||||
| First Posted Date ICMJE | June 21, 2019 | ||||||||
| Last Update Posted Date | December 29, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 1, 2019 | ||||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| 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 | Allocation: N/A 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2021 | ||||||||
| Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| 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 |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Ashwin Vaidyanathan, MD, 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 | December 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
