Heart Failure Clinical Trial

SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Summary

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

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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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT03836079

Recruitment Status:

Recruiting

Sponsor:

Abiomed Inc.

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There are 16 Locations for this study

See Locations Near You

Colorado Heart & Vascular
Lakewood Colorado, 80226, United States More Info
Nima Aghili, MD
Principal Investigator
Medstar Washington Hospital Center
Washington District of Columbia, 20010, United States More Info
Farooq Sheikh
Principal Investigator
Tampa General Hospital
Tampa Florida, 33606, United States More Info
Debbie Rinde-Hoffman
Principal Investigator
Iaona Dumitru
Principal Investigator
Northwestern
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Kansas University Medical Center
Kansas City Kansas, 66160, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Precardia
Contact
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States More Info
Peter Eckman
Principal Investigator
CentraCare Heart & Vascular Center
Saint Cloud Minnesota, 56303, United States
OhioHealth
Columbus Ohio, 43214, United States More Info
Anupam Basuray
Principal Investigator
Providence Health & Services
Portland Oregon, 97225, United States More Info
Precardia
Contact
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
preCardia
Contact
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Precardia
Contact
Baylor College of Medicine
Houston Texas, 77030, United States More Info
Ajith Nair
Principal Investigator
Houston Methodist
Houston Texas, 77030, United States More Info
Precardia
Contact
Baylor, Scott & White Medical Center - Temple
Temple Texas, 76508, United States More Info
Jaime Hernandez-Monfort
Principal Investigator
Inova Health System
Falls Church Virginia, 22042, United States More Info
Shashank Desai
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT03836079

Recruitment Status:

Recruiting

Sponsor:


Abiomed Inc.

How clear is this clinincal trial information?

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