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

Reprieve Cardiovascular

Status: Completed

Conditions: Heart Failure

Treatments: Other: Fluid Management; Device: Reprieve Cardiovascular System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05015764

RCV-0005

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Reprieve Cardiovascular System

Experimental group

Treatment:

Device: Reprieve Cardiovascular System

Standard of Care

Active Comparator group

Treatment:

Other: Fluid Management