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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02682849
Other study ID # 15-006388
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2016
Est. completion date March 2020

Study information

Verified date October 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 2020
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
John M. Stulak

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Discharge from operating room for index-surgery through hospital discharge - approximate 30 days
Secondary Number of episodes of new on set of post operative atrial fibrillations (POAS) 30 day
Secondary Number of readmissions for any diagnosis of RBS or POAS re-occurrences 30 day
See also
  Status Clinical Trial Phase
Terminated NCT05308589 - CPPF After General Cardiac Surgery N/A

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