SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure

Safety and performance evaluation of the preCARDIA System for patients with ADHF.

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.

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