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 Sex
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

ArmDescriptionAssigned Intervention
Experimental
ADHF Patients 		Treatment with preCARDIA System
  • Device: preCARDIA system
    Intermittent occlusion of the SVC

More Details

Status
Completed
Sponsor
Abiomed Inc.

Study Contact

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.