SVC Occlusion in Subjects With Acute Decompensated Heart Failure

NCT ID: NCT03836079

Last Updated: 2025-09-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2025-02-18

Brief Summary

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Safety and performance evaluation of the preCARDIA System for patients with ADHF.

Detailed Description

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The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.

Conditions

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Acute Decompensated Heart Failure Acute Heart Failure Congestive Heart Failure Heart Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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ADHF Patients

Treatment with preCARDIA System

Group Type EXPERIMENTAL

preCARDIA system

Intervention Type DEVICE

Intermittent occlusion of the SVC

Interventions

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preCARDIA system

Intermittent occlusion of the SVC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* NYHA Class III-IV heart failure
* Subjects with inadequate diuresis
* Stage C-D systolic heart failure

Exclusion Criteria

* Active myocardial ischemia or acute coronary syndrome (ACS)
* Severe aortic or mitral valve insufficiency
* Severe peripheral vascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Colorado Heart & Vascular

Lakewood, Colorado, United States

Site Status

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Northwestern

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

Site Status

OhioHealth

Columbus, Ohio, United States

Site Status

Providence Health & Services

Portland, Oregon, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Houston Methodist

Houston, Texas, United States

Site Status

Baylor, Scott & White Medical Center - Temple

Temple, Texas, United States

Site Status

Inova Health System

Falls Church, Virginia, United States

Site Status

Countries

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United States

References

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Kapur NK, Kiernan MS, Gorgoshvili I, Yousefzai R, Vorovich EE, Tedford RJ, Sauer AJ, Abraham J, Resor CD, Kimmelstiel CD, Benzuly KH, Steinberg DH, Messer J, Burkhoff D, Karas RH. Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study. Circ Heart Fail. 2022 Feb;15(2):e008934. doi: 10.1161/CIRCHEARTFAILURE.121.008934. Epub 2022 Jan 10.

Reference Type DERIVED
PMID: 35000420 (View on PubMed)

Other Identifiers

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101773-002

Identifier Type: -

Identifier Source: org_study_id

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