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Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)

NCT04227977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-10-25

No results posted yet for this study

Summary

The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.

Conditions

  • Cardiorenal Syndrome

Interventions

DEVICE

JuxtaFlow System

The JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis.

Sponsors & Collaborators

  • 3ive Labs

    lead INDUSTRY

Principal Investigators

  • Wilson Tang, MD · The Cleveland Clinic

  • Alex Parker, MD · Univ. of Florida, Gainesville

  • Wayne Old, MD · Sentara Norfolk General Hospital

  • Shweta Bansal, MD · Univ. of Texas Health, San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2023-05-01
Completion
2023-10-20
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04227977 on ClinicalTrials.gov