SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Abiomed Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Acute Decompensated Heart Failure Acute Heart Failure Congestive Heart Failure Heart Diseases

Interventions

preCARDIA systemDEVICE

Intermittent occlusion of the SVC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (17)

Colorado Heart & Vascular

Lakewood, Colorado, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Freedom from Major Adverse Events through 90 days post-discharge.

MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.

Time frame: 90 days post-discharge

Data from ClinicalTrials.gov

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