Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
NCT ID: NCT05015764
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2021-04-12
2022-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Reprieve Cardiovascular System
Reprieve Cardiovascular System
System with Fluid Management Module
Standard of Care
Fluid Management
Removal of excess extracellular fluid using diuretics
Interventions
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Fluid Management
Removal of excess extracellular fluid using diuretics
Reprieve Cardiovascular System
System with Fluid Management Module
Eligibility Criteria
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Inclusion Criteria
2. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Reprieve Cardiovascular, Inc
INDUSTRY
Responsible Party
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Locations
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Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Countries
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Other Identifiers
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RCV-0005
Identifier Type: -
Identifier Source: org_study_id
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