Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Reprieve Cardiovascular System; Other: Fluid Management

• Registration Number: NCT05015764
• Lead Sponsor: Reprieve Cardiovascular, Inc

Brief Summary

Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study

Detailed Description

The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-20
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Status Verified: 2022-11
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Hospitalized with a diagnosis of heart failure
2. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria

1. Inability to place Foley catheter or IV catheter
2. Hemodynamic instability
3. Dyspnea due primarily to non-cardiac causes
4. Acute infection with evidence of systemic involvement
5. Inability to follow instructions or comply with follow-up procedures.
6. Other concomitant disease or condition that investigator deems unsuitable for the study
7. Enrollment in another interventional trial during the index hospitalization
8. Life expectancy less than 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reprieve Cardiovascular System	Reprieve Cardiovascular System	-
Standard of Care	Fluid Management	-

Primary Outcome Measures

Name	Time	Method
Device and Procedure related AEs and SAEs	Through study completion, an average of 90 days	Rate of device and procedure related AEs and SAEs
Fractional Excretion of Sodium measured during therapy	End of treatment, an average of 24 hours	Average fractional excretion of sodium across all patients measured during therapy

Trial Locations

Locations (1)

Israeli-Georgian Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia