Trial Outcomes & Findings for Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair (NCT NCT03993938)

Last Updated: 2022-06-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Intraprocedure

Results posted on

2022-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Patients for TMVR Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus. 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
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients for TMVR n=30 Participants Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus. 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	80 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
BMI	25.4 kg/m^2 n=5 Participants
Ejection fraction	47.5 % n=5 Participants
Mean pulmonary artery (PA) pressure	43 mm Hg n=5 Participants

PRIMARY outcome

Timeframe: Intraprocedure

Outcome measures

Outcome measures
Measure	Patients for TMVR n=30 Participants Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus. 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
Delta PVI to Delta LAP Correlation During MitraClip Placement Delta PVI (percentage change)	4.30 percentage of baseline (pre-MitraClip) Interval -15.06 to 40.91
Delta PVI to Delta LAP Correlation During MitraClip Placement Delta LAP (percentage change)	-26.14 percentage of baseline (pre-MitraClip) Interval -42.36 to -11.46

Adverse Events

Patients for TMVR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Trevor Szymanski MD

Henry Ford Health System

Phone: (313) 622-4168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place