Active Clearance Technology (ACT) Registry

John M. Stulak500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Retained Blood Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of interventions to Treat Retained Blood Syndrome

Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.

Time frame: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days

Secondary Outcomes

Number of episodes of new on set of post operative atrial fibrillations (POAS)

Time frame: 30 day

Number of readmissions for any diagnosis of RBS or POAS re-occurrences

Time frame: 30 day

Data from ClinicalTrials.gov

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