NCT03836079

SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Decompensated Heart Failure
• Acute Heart Failure
• Congestive Heart Failure
• Heart Diseases

Interventions

Type	Name	Description
DEVICE	preCARDIA system	Intermittent occlusion of the SVC

Timeline

• Start date: 2019-07-31
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2019-02-11
• Last updated: 2025-09-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study