SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Last updated: September 29, 2025
Sponsor: Abiomed Inc.
Overall Status: Completed

Phase

N/A

Condition

Hyponatremia

Chest Pain

Heart Failure

Treatment

preCARDIA system

Clinical Study ID

NCT03836079
101773-002
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • NYHA Class III-IV heart failure

  • Subjects with inadequate diuresis

  • Stage C-D systolic heart failure

Exclusion

Exclusion Criteria:

  • Active myocardial ischemia or acute coronary syndrome (ACS)

  • Severe aortic or mitral valve insufficiency

  • Severe peripheral vascular disease

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: preCARDIA system
Phase:
Study Start date:
July 31, 2019
Estimated Completion Date:
February 18, 2025

Study Description

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.

Connect with a study center

  • Colorado Heart & Vascular

    Lakewood, Colorado 80226
    United States

    Site Not Available

  • Colorado Heart & Vascular

    Lakewood 5427946, Colorado 5417618 80226
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Northwestern

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Northwestern

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Tufts Medical Center

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • CentraCare Heart & Vascular Center

    Saint Cloud 5044407, Minnesota 5037779 56303
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • OhioHealth

    Columbus, Ohio 43214
    United States

    Site Not Available

  • OhioHealth

    Columbus 4509177, Ohio 5165418 43214
    United States

    Site Not Available

  • Providence Health & Services

    Portland, Oregon 97225
    United States

    Site Not Available

  • Providence Health & Services

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor, Scott & White Medical Center - Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Houston Methodist

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Baylor, Scott & White Medical Center - Temple

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

  • Inova Health System

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Inova Health System

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

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