Trial Outcomes & Findings for Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) (NCT NCT03937570)
NCT ID: NCT03937570
Last Updated: 2021-11-02
Results Overview
peak oxygen uptake measured by cardiopulmonary exercise test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
three months
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
EO GROUP
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)
Baseline characteristics by cohort
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
VO2 peak
|
13.2 mL/kg/min
STANDARD_DEVIATION 2.5 • n=5 Participants
|
13.8 mL/kg/min
STANDARD_DEVIATION 2.4 • n=7 Participants
|
13.5 mL/kg/min
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: three monthspeak oxygen uptake measured by cardiopulmonary exercise test
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
VO2 Peak
BASELINE
|
13.2 mL/Kg/min
Standard Deviation 2.5
|
13.8 mL/Kg/min
Standard Deviation 2.4
|
|
VO2 Peak
3 MONTHS-FOLLOW UP
|
14.2 mL/Kg/min
Standard Deviation 2.5
|
13.2 mL/Kg/min
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Three monthsRate of hospitalizations for: device thrombosis, hemorrhagic events, infections, right heart failure, arrhythmias.
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
Number of Participants With LVAD-related Hospitalizations
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Three monthsChanges in quality of life perceived by EuroQoL (quality of life) Scale. It is an instrument which evaluates the quality of life measuring with one question: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to these question (1 = no problems; 2 = some problems; 3 = extreme problems) are converted into EQ-5D index, an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
QoL: The EQ-5D Questionnaire
BASELINE
|
0.796 score on a scale
Standard Deviation 0.1
|
0.804 score on a scale
Standard Deviation 0.09
|
|
QoL: The EQ-5D Questionnaire
3 MONTHS-FOLLOW UP
|
0.85 score on a scale
Standard Deviation 0.08
|
0.8 score on a scale
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Three monthsNt-proBNP levels
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
Nt-proBNP
BASELINE
|
1743 ng/L
Standard Deviation 1453
|
1759 ng/L
Standard Deviation 1154
|
|
Nt-proBNP
3 MONTHS-FOLLOW UP
|
1484 ng/L
Standard Deviation 1251
|
1538 ng/L
Standard Deviation 1020
|
SECONDARY outcome
Timeframe: Three monthsFractional area change of right ventricle assessed by echocardiography
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
Right Ventricular Function
BASELINE
|
36.5 percentage of fractional area change
Standard Deviation 3.8
|
35.8 percentage of fractional area change
Standard Deviation 4.1
|
|
Right Ventricular Function
3 MONTHS-FOLLOW UP
|
36.8 percentage of fractional area change
Standard Deviation 3.2
|
35.7 percentage of fractional area change
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Three monthsCardiopulmonary exercise time
Outcome measures
| Measure |
EO GROUP
n=13 Participants
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
echo-optimization: LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
|
CONTROL GROUP
n=14 Participants
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
|
|---|---|---|
|
CPET Exercise Time
BASELINE
|
490 seconds
Standard Deviation 98
|
504 seconds
Standard Deviation 103
|
|
CPET Exercise Time
3 MONTHS-FOLLOW UP
|
526 seconds
Standard Deviation 116
|
499 seconds
Standard Deviation 107
|
Adverse Events
EO GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL GROUP
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
Marzia Lilliu, MD, PhD
Division of Cardiac Surgery, Department of Surgery - University of Verona
Phone: +39 3281383539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place