SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Conditions

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

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.

Yousefzai R, Bhimaraj A, Kiernan MS, Abraham J, Gorgoshvili I, Tedford RJ, Desai S, Vorovich EE, Benzuly KH, Miranda D, Kanwar MK, Sauer AJ, Rinde-Hoffman DA, Dumitru I, Hernandez-Montfort J, Aghili N, Sheikh FH, Basuray A, Bodnar J, Curran J, Burkhoff D, Kapur NK.

2025-12-11

10.1016/j.jchf.2025.102841

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study

Navin K. Kapur, Michael S. Kiernan, Irakli Gorgoshvili, Rayan Yousefzai, Esther E. Vorovich et al. (15 authors)

Circulation Heart Failure2022-01-1032 citations

10.1161/circheartfailure.121.008934

Interventions

DEVICEpreCARDIA system

Intermittent occlusion of the SVC

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed