SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Purpose
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Conditions
- Acute Decompensated Heart Failure
- Acute Heart Failure
- Congestive Heart Failure
- Heart Diseases
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ADHF Patients |
Treatment with preCARDIA System |
|
Recruiting Locations
Medstar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Abiomed Inc.
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.