CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 330 enrolled
Drug / intervention
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Featuredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03469570
NCT03469570N/ACompleted

A Validation of the Assisted Fluid Management Feature

Edwards Lifesciences·interventional·Posted Mar 19, 2018·Updated Nov 8, 2024

In Brief

A clinical study evaluating EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature for Non-Cardiac/ Non-Thoracic Surgery and 3 related conditions. Completed, enrolled 330 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartApr 19, 2018
Primary CompletionDec 21, 2018
Study CompletionJan 25, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago

Interventions

EV1000 Clinical Platform with Assisted Fluid Management (AFM) Featuredevice

Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.