Clinical trial NCT03836079: SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Official title: Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Acute Heart Failure
Congestive Heart Failure
Heart Diseases
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Freedom from Major Adverse Events through 90 days post-discharge.
timeFrame: 90 days post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Colorado Heart & Vascular
state: Colorado
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Temple
country: United States
facility: Baylor, Scott & White Medical Center - Temple
state: Texas
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
Study officials:
References:
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.