Status:
COMPLETED
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Lead Sponsor:
Abiomed Inc.
Conditions:
Acute Decompensated Heart Failure
Acute Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 approac...
Eligibility Criteria
Inclusion
- NYHA Class III-IV heart failure
- Subjects with inadequate diuresis
- Stage C-D systolic heart failure
Exclusion
- Active myocardial ischemia or acute coronary syndrome (ACS)
- Severe aortic or mitral valve insufficiency
- Severe peripheral vascular disease
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03836079
Start Date
July 31 2019
End Date
February 18 2025
Last Update
September 30 2025
Active Locations (17)
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1
Colorado Heart & Vascular
Lakewood, Colorado, United States, 80226
2
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
Northwestern
Chicago, Illinois, United States, 60611