A Validation of the Assisted Fluid Management Feature
Phase: NA
Conditions: Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
Sponsor: Edwards Lifesciences

 
 
 
 
A Validation of the Assisted Fluid Management Feature 
CLINICAL STUDY PROTOCOL 
Medical Device: EV1000 Platform with Acumen™ Assisted Fluid Management Feature 
Date: October 25, 2018 
 
 
 
NCT03469570 

AFM Clinical Study 
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Title: 
A  Validation of the Acumen™ Assisted Fluid Management (AFM) 
Short Title: 
AFM Study 
Purpose: 
The primary objective of this study is to evaluate the performance of the Acumen™ 
Assisted Fluid Management (AFM) Feature in its ability to predict a subject’s fluid 
responsiveness. The validity of the fluid bolus recommendation will be analyzed by 
reporting the number of recommendations followed by delivered boluses that did and did 
not have a stroke volume response meeting the set fluid strategy.  
Subjects enrolled in the validation study will have their fluid management decisions guided 
by the AFM Feature.  The decision to provide fluid as recommended by the AFM Feature 
lies solely with the treating investigator.  When a fluid recommendation is made by the 
AFM Feature, the investigator will assess the subject holistically prior to accepting or 
declining the system recommendation. 
Device Name: 
 Edwards Lifesciences Acumen™ Assisted Fluid Management (AFM) software 
Overall Design: 
Pragmatic, multi-site, clinical study with subjects allocated to a single arm 
Sample Size: 
330 Subjects 
Number of Sites: 
Up to 20 sites 
Subject 
Participation: 
Subject participation will include: 

Screening / consent

Placement of arterial line and use of Edwards FloTrac IQ

Undergo planned surgical procedure

Fluid management during surgical procedure

Data Collection

Device related adverse event/serious adverse event data collection, if applicable
Enrollment Period: 
Anticipated to last 6 months 

AFM Clinical Study 
Page 2 of 2 
Clinical Study 
Population: 
Inclusion Criteria: 
1.
Be ≥ 18 years of age
2.
Non-cardiac/Non-thoracic 
surgery 
(e.g., 
abdominal 
surgery, 
combined
abdominal/pelvic surgery, major peripheral vascular surgery) expected to last >2
hours post anesthesia induction
3.
Procedure will require Mechanical ventilation
4.
American Society of Anesthesiology (ASA) Score 3 or 4
5.
Expected arterial line placement for surgical procedure and general anesthesia
6.
Projected to receive hemodynamic monitoring during surgical procedure
7.
Participate or have authorized representative participate in the Informed Consent
process and sign/date the IRB approved informed consent form
Exclusion Criteria 
8.
Are < 18 years of age
9.
Have a body mass index ≥ 35 kg/m²
10. Known acute congestive heart failure
11. Known aortic stenosis with valve area ≤ 1.5 cm2
12. Known moderate to severe aortic regurgitation
13. Known moderate to severe mitral regurgitation
14. Known moderate to severe mitral stenosis
15. Current persistent atrial fibrillation
16. Liver resection procedure
17. Neurosurgery
18. Open chest procedures
19. Patient or surgical procedure type known as an SVV limitation16  (e.g. tidal volume
<8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac
arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory
Rate (HR/RR) ratio <3.6)
20. Emergent or cardiovascular surgical procedure
21. Patient who is confirmed to be pregnant
22. Participation in any other drug, device, or biologic study concomitantly, or within
the last 30 days (which may clinically interfere with this Clinical Study)
23. Refusal of patient or authorized representative to sign consent
Endpoints: 
Primary effectiveness endpoint: 
Evaluate the performance of the AFM feature in its ability to predict the fluid 
responsiveness of a subject. 
Primary safety endpoint: 
The primary safety endpoint is the assessment of serious adverse events which may be 
related to the Acumen™ Assisted Fluid Management Feature.