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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reprieve Cardiovascular System

Group Type EXPERIMENTAL

Reprieve Cardiovascular System

Intervention Type DEVICE

System with Fluid Management Module

Standard of Care

Group Type ACTIVE_COMPARATOR

Fluid Management

Intervention Type OTHER

Removal of excess extracellular fluid using diuretics

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluid Management

Removal of excess extracellular fluid using diuretics

Intervention Type OTHER

Reprieve Cardiovascular System

System with Fluid Management Module

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reprieve Cardiovascular, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, , Georgia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Georgia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RCV-0005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The REACT-ICD Trial
NCT02439424 UNKNOWN PHASE1/PHASE2
Cardionomic STOP-ADHF Study
NCT04814134 COMPLETED NA