SVC Occlusion in Subjects With Acute Decompensated Heart Failure (VENUS-HF)

Abiomed

Status: Enrolling

Conditions: Acute Heart Failure; Acute Decompensated Heart Failure; Heart Diseases; Congestive Heart Failure

Treatments: Device: preCARDIA system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03836079

101773-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

ADHF Patients

Experimental group

Description:

Treatment with preCARDIA System

Treatment:

Device: preCARDIA system