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

Abiomed logo

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

Trial contacts and locations

17

Loading...

Central trial contact

Kelsey Hedquist

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems