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Active Clearance Technology (ACT) Registry

J

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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