SVC Occlusion in Subjects With Acute Decompensated Heart Failure
NCT03836079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-09-30
Summary
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Conditions
- Acute Decompensated Heart Failure
- Acute Heart Failure
- Congestive Heart Failure
- Heart Diseases
Interventions
- DEVICE
-
preCARDIA system
Intermittent occlusion of the SVC
Sponsors & Collaborators
-
Abiomed Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-31
- Primary Completion
- 2025-02-18
- Completion
- 2025-02-18
- FDA Device
- Yes
Countries
- United States
Study Locations
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