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Reprieve ADHF EFS IDE

NCT03866551 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-07

No results posted yet for this study

Summary

This is a prospective, single arm, early feasibility study (EFS) designed to evaluate the safety and device performance of The RenalGuard System in the management of patients admitted with signs and symptoms of congestive heart failure who require diuresis for the treatment of volume overload.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Reprieve Cardiovascular System

The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.

Sponsors & Collaborators

  • CardioRenal Systems, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-12-01
Completion
2020-02-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866551 on ClinicalTrials.gov