Active Clearance Technology (ACT) Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006388
NCT ID: NCT02682849
Sponsor Protocol Number: 15-006388
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
- Patient undergoing cardiac surgery via sternotomy
Exclusion Criteria:
- Robotic surgery
- Any access via thoracotomy
- Any condition deemed inappropriate for inclusion by the investigators.
- Intolerance to implantable silicone materials
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Stulak, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available