SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Last updated: January 7, 2025
Sponsor: Abiomed Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Heart Disease

Chest Pain

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: 100
Treatment Group(s): 1
Primary Treatment: preCARDIA system
Phase:
Study Start date:
July 31, 2019
Estimated Completion Date:
March 31, 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

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 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

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 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

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • OhioHealth

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Providence Health & Services

    Portland, Oregon 97225
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 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

  • Inova Health System

    Falls Church, Virginia 22042
    United States

    Site Not Available

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