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

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

Recruiting Locations

Medstar Washington Hospital Center
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Abiomed Inc.

Study Contact

Kelsey Hedquist
651-252-1773
venushf@abiomed.com

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.