SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Not Applicable

Active, not recruiting

• Conditions: Acute Heart Failure; Congestive Heart Failure; Acute Decompensated Heart Failure; Heart Diseases
• Interventions: Device: preCARDIA system

• Registration Number: NCT03836079
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-07-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADHF Patients	preCARDIA system	Treatment with preCARDIA System

Primary Outcome Measures

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

Trial Locations

Locations (17)

Colorado Heart & Vascular; 🇺🇸 Lakewood, Colorado, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Northwestern; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

CentraCare Heart & Vascular Center; 🇺🇸 Saint Cloud, Minnesota, United States

OhioHealth; 🇺🇸 Columbus, Ohio, United States

Providence Health & Services; 🇺🇸 Portland, Oregon, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Baylor, Scott & White Medical Center - Temple; 🇺🇸 Temple, Texas, United States

Inova Health System; 🇺🇸 Falls Church, Virginia, United States