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NCT03836079 Clinical Trial

SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Heart Diseases Clinical Trial

— VENUS-HF  

Official title:
Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03836079
Other study ID # 101773-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 31, 2019
Est. completion date October 2024

Study information
Verified date April 2024
Source Abiomed Inc.
Contact Kelsey Hedquist
Phone 651-252-1773
Email venushf@abiomed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• preCARDIA system
Intermittent occlusion of the SVC

Locations
Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern Chicago Illinois
United States University of Chicago Chicago Illinois
United States OhioHealth Columbus Ohio
United States Inova Health System Falls Church Virginia
United States Baylor College of Medicine Houston Texas
United States Houston Methodist Houston Texas
United States Kansas University Medical Center Kansas City Kansas
United States Colorado Heart & Vascular Lakewood Colorado
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Providence Health & Services Portland Oregon
United States CentraCare Heart & Vascular Center Saint Cloud Minnesota
United States Tampa General Hospital Tampa Florida
United States Baylor, Scott & White Medical Center - Temple Temple Texas
United States Medstar Washington Hospital Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 90 days post-discharge
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