Clinical Trials Logo

Clinical Trial Summary

This is a prospective, single arm, early feasibility study 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.


Clinical Trial Description

This is a prospective, single arm, early feasibility study 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. Subjects will be referred by their physician if he/she feels that the subject could benefit from observed diuresis in a hospital setting.

The device being utilized is called The RenalGuard® System (The System). By default, The System infuses a volume of hydration fluid equal to the volume of urine output. This is known as matched hydration. In addition, the clinician has the ability to adjust the matched setting such that RenalGuard can infuse hydration fluid to achieve a positive fluid balance (e.g. +100 ml/hr.) or a negative fluid balance (e.g. -100 ml/hr.). The purpose of this balanced fluid replacement is to prevent hypovolemia that may lead to hypotension and vital organ dysfunction, or fluid overload that may lead to shortness of breath in subjects in whom high urine output is desired.

All patients will be treated with The RenalGuard System for a minimum of 24-hours, and possibly longer, at the investigators discretion. They will be followed for 30 days post discharge. The protocol will enroll up to 40 subjects to develop the clinical algorithm required to optimally and safely perform removal of volume. The study will be conducted in up to 5 sites in Europe. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03897842
Study type Interventional
Source CardioRenal Systems, Inc.
Contact Andrew Halpert
Phone 5085418800
Email info@reprievecardio.com
Status Recruiting
Phase N/A
Start date March 16, 2017
Completion date January 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Terminated NCT05594940 - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Completed NCT04394754 - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure N/A
Active, not recruiting NCT01385176 - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) N/A
Not yet recruiting NCT05516290 - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Terminated NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) Phase 4
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2