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OpenTrials
Completed

NCT Number: NCT03836079

SVC Occlusion in Subjects With Acute Decompensated Heart Failure

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

Completed

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Heart & Vascular, Lakewood, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preCARDIA system

Device

Intermittent occlusion of the SVC

Primary outcomes

  1. Freedom from Major Adverse Events through 90 days post-discharge.

    Time frame: 90 days post-discharge

    MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure

Acronym: VENUS-HF

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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