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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015764
• Other study ID #: RCV-0005
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: November 2022
• Source: Reprieve Cardiovascular, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Fluid Management
Removal of excess extracellular fluid using diuretics

Device:
• Reprieve Cardiovascular System
System with Fluid Management Module

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Reprieve Cardiovascular, Inc

Country where clinical trial is conducted

Georgia, 

Outcome

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