Active Clearance Technology (ACT) Registry

John M. Stulak

Status: Completed

Conditions: Retained Blood Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02682849

15-006388

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
2. Patient undergoing cardiac surgery via sternotomy

Exclusion criteria

1. Robotic surgery
2. Any access via thoracotomy
3. Any condition deemed inappropriate for inclusion by the investigators.
4. Intolerance to implantable silicone materials.

Trial design

500 participants in 2 patient groups

Retrospective cohort

Prospective PleuralFlow cohort