Mitral RegurgitationNCT03993938
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
A study testing PVI measurement in people with Mitral Regurgitation, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- PVI measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with mitral regurgitation undergoing transcatheter mitral valve repair(TMVR) with Mitra-Clip(R) at Henry Ford Hospital - Main Campus.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mitral Regurgitation
- Being tested
- PVI measurement
- Keywords
- transcatheter mitral valve repair, pleth variability index, Mitraclip
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI measurementDevice
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 group | Role | What they receive |
|---|---|---|
| Patients for TMVR | Experimental | Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus. Receives: Device: PVI measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta PVI to Delta LAP Correlation During MitraClip Placement
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
Measured: Intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Oct 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwin Vaidyanathan, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993938
- Sponsor's protocol ID
- 1
- Status last verified
- May 2022
- First submitted
- 17 Feb 2019
- Last updated
- 24 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vaidyanathan A, Guruswamy J, Saluja A, Eng M, Szymanski T. Use of Pleth Variability Index as a Non-invasive, Dynamic Indicator of Left Atrial Pressure Change During MitraClip: Transcatheter Mitral Valve Repair. Semin Cardiothorac Vasc Anesth. 2024 Sep;28(3):147-151. doi: 10.1177/10892532241260535. Epub 2024 Jun 12.
PubMed 38864441
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT03993938
- Acronym / sponsor ID
- 1
- Conditions
- Mitral Regurgitation
- Keywords
- transcatheter mitral valve repair, pleth variability index, Mitraclip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Posted 24 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients for TMVR | Experimental | Device: PVI measurementPatients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients with mitral regurgitation undergoing transcatheter mitral valve repair(TMVR) with Mitra-Clip(R) at Henry Ford Hospital - Main Campus.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVI measurementMasimo 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 | Device | Patients for TMVR |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38864441Vaidyanathan A, Guruswamy J, Saluja A, Eng M, Szymanski T. Use of Pleth Variability Index as a Non-invasive, Dynamic Indicator of Left Atrial Pressure Change During MitraClip: Transcatheter Mitral Valve Repair. Semin Cardiothorac Vasc Anesth. 2024 Sep;28(3):147-151. doi: 10.1177/10892532241260535. Epub 2024 Jun 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI measurement in people with Mitral Regurgitation, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta PVI to Delta LAP Correlation During MitraClip Placement (time frame: Intraprocedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.