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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
preCARDIA system
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medstar Washington Hospital Center
  • Northwestern
  • University of Chicago
  • Kansas University Medical Center
  • Tufts Medical CenterRecruiting
  • Minneapolis Heart Institute Foundation
  • CentraCare Heart & Vascular Center
  • Cleveland Clinic Foundation
  • OhioHealth
  • Providence Health & ServicesRecruiting
  • Allegheny General HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Baylor College of Medicine
  • Houston MethodistRecruiting
  • Baylor, Scott & White Medical Center - Temple
  • Inova Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHF Patients

Arm Description

Treatment with preCARDIA System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2019
Last Updated
October 2, 2023
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03836079
Brief Title
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Acronym
VENUS-HF
Official Title
Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure, Acute Heart Failure, Congestive Heart Failure, Heart Diseases

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHF Patients
Arm Type
Experimental
Arm Description
Treatment with preCARDIA System
Intervention Type
Device
Intervention Name(s)
preCARDIA system
Intervention Description
Intermittent occlusion of the SVC
Primary Outcome Measure Information:
Title
Freedom from Major Adverse Events through 90 days post-discharge.
Description
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.
Time Frame
90 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Hedquist
Phone
651-252-1773
Email
venushf@abiomed.com
Facility Information:
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farooq Sheikh
Facility Name
Northwestern
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Terminated
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Terminated
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Terminated
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Precardia
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Eckman
Facility Name
CentraCare Heart & Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Terminated
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Lee
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anupam Basuray
Facility Name
Providence Health & Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Precardia
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
preCardia
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Precardia
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajith Nair
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Precardia
Facility Name
Baylor, Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Hernandez-Monfort
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shashank Desai

12. IPD Sharing Statement

Citations:
PubMed Identifier
35000420
Citation
Kapur NK, Kiernan MS, Gorgoshvili I, Yousefzai R, Vorovich EE, Tedford RJ, Sauer AJ, Abraham J, Resor CD, Kimmelstiel CD, Benzuly KH, Steinberg DH, Messer J, Burkhoff D, Karas RH. Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study. Circ Heart Fail. 2022 Feb;15(2):e008934. doi: 10.1161/CIRCHEARTFAILURE.121.008934. Epub 2022 Jan 10.
Results Reference
derived

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SVC Occlusion in Subjects With Acute Decompensated Heart Failure

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