SVC Occlusion in Subjects With Acute Decompensated Heart Failure
VENUS-HF
Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
1 other identifier
interventional
60
1 country
17
Brief Summary
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2025
CompletedSeptember 30, 2025
September 1, 2025
5.6 years
February 7, 2019
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from Major Adverse Events through 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.
90 days post-discharge
Study Arms (1)
ADHF Patients
EXPERIMENTALTreatment with preCARDIA System
Interventions
Eligibility Criteria
You may qualify if:
- NYHA Class III-IV heart failure
- Subjects with inadequate diuresis
- Stage C-D systolic heart failure
You may not qualify if:
- Active myocardial ischemia or acute coronary syndrome (ACS)
- Severe aortic or mitral valve insufficiency
- Severe peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (17)
Colorado Heart & Vascular
Lakewood, Colorado, 80226, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
OhioHealth
Columbus, Ohio, 43214, United States
Providence Health & Services
Portland, Oregon, 97225, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist
Houston, Texas, 77030, United States
Baylor, Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
Inova Health System
Falls Church, Virginia, 22042, United States
Related Publications (1)
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.
PMID: 35000420DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 11, 2019
Study Start
July 31, 2019
Primary Completion
February 18, 2025
Study Completion
February 18, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share