VENUS-HF: SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Study Details
Study Description
Brief Summary
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ADHF Patients Treatment with preCARDIA System |
Device: preCARDIA system
Intermittent occlusion of the SVC
|
Outcome Measures
Primary Outcome Measures
- Freedom from Major Adverse Events through 30 days. [30 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
NYHA Class III-IV heart failure
-
Subjects with inadequate diuresis
-
Stage C-D systolic heart failure
Exclusion Criteria:
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Active myocardial ischemia or acute coronary syndrome (ACS)
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Severe aortic or mitral valve insufficiency
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Severe peripheral vascular disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwestern | Chicago | Illinois | United States | 60611 |
2 | University of Chicago | Chicago | Illinois | United States | 60637 |
3 | Kansas University Medical Center | Kansas City | Kansas | United States | 66160 |
4 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
5 | Providence Health & Services | Portland | Oregon | United States | 97225 |
6 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
7 | Houston Methodist | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Abiomed Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 101773-002