Acute Decompensated Heart FailureVENUS-HFNCT03836079
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
A study testing preCARDIA system in people with Acute Decompensated Heart Failure and Acute Heart Failure, run by Abiomed Inc. at 17 sites in United States.
Trial summary
Safety and performance evaluation of the preCARDIA System for patients with ADHF. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure, Acute Heart Failure, Congestive Heart Failure
- What is being tested?
- preCARDIA system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 17 sitesUnited States
- Study dates
- 31 Jul 2019to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA Class III-IV heart failure
- Subjects with inadequate diuresis
- Stage C-D systolic heart failure
Who cannot join
- Active myocardial ischemia or acute coronary syndrome (ACS)
- Severe aortic or mitral valve insufficiency
- Severe peripheral vascular disease
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
OhioHealth
Columbus, Ohio, 43214
Inova Health System
Falls Church, Virginia, 22042
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
Colorado Heart & Vascular
Lakewood, Colorado, 80226
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Providence Health & Services
Portland, Oregon, 97225
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Tampa General Hospital
Tampa, Florida, 33606
Baylor, Scott & White Medical Center - Temple
Temple, Texas, 76508
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Read the detailed 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.
- Conditions
- Acute Decompensated Heart Failure, Acute Heart Failure, Congestive Heart Failure, Heart Diseases
- Being tested
- preCARDIA system
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preCARDIA systemDevice
Intermittent occlusion of the SVC
| Study group | Role | What they receive |
|---|---|---|
| ADHF Patients | Experimental | Treatment with preCARDIA System Receives: Device: preCARDIA system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start31 Jul 2019
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836079
- Sponsor's protocol ID
- 101773-002
- Acronym
- VENUS-HF
- Status last verified
- Sep 2025
- First submitted
- 7 Feb 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yousefzai R, Bhimaraj A, Kiernan MS, Abraham J, Gorgoshvili I, Tedford RJ, Desai S, Vorovich EE, Benzuly KH, Miranda D, Kanwar MK, Sauer AJ, Rinde-Hoffman DA, Dumitru I, Hernandez-Montfort J, Aghili N, Sheikh FH, Basuray A, Bodnar J, Curran J, Burkhoff D, Kapur NK. Mechanically Reducing Cardiac Preload With the preCARDIA System in Acutely Decompensated Heart Failure. JACC Heart Fail. 2026 Mar;14(3):102841. doi: 10.1016/j.jchf.2025.102841. Epub 2025 Dec 13.
PubMed 41389079Kapur 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.
PubMed 35000420
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03836079
- Acronym / sponsor ID
- VENUS-HF / 101773-002
- Conditions
- Acute Decompensated Heart Failure, Acute Heart Failure, Congestive Heart Failure, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Detailed 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHF Patients | Experimental | Device: preCARDIA systemTreatment with preCARDIA System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA Class III-IV heart failure
- Subjects with inadequate diuresis
- Stage C-D systolic heart failure
Key exclusion criteria (3 listed)
- Active myocardial ischemia or acute coronary syndrome (ACS)
- Severe aortic or mitral valve insufficiency
- Severe peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preCARDIA systemIntermittent occlusion of the SVC | Device | ADHF Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 41389079Yousefzai R, Bhimaraj A, Kiernan MS, Abraham J, Gorgoshvili I, Tedford RJ, Desai S, Vorovich EE, Benzuly KH, Miranda D, Kanwar MK, Sauer AJ, Rinde-Hoffman DA, Dumitru I, Hernandez-Montfort J, Aghili N, Sheikh FH, Basuray A, Bodnar J, Curran J, Burkhoff D, Kapur NK. Mechanically Reducing Cardiac Preload With the preCARDIA System in Acutely Decompensated Heart Failure. JACC Heart Fail. 2026 Mar;14(3):102841. doi: 10.1016/j.jchf.2025.102841. Epub 2025 Dec 13.
- Derived from this study: PubMed 35000420Kapur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preCARDIA system in people with Acute Decompensated Heart Failure and Acute Heart Failure, run by Abiomed Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Major Adverse Events through 90 days post-discharge. (time frame: 90 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.