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Device
Active Tube Clearance drainage for Cardiac Tamponade (ACT-POAF Trial)
N/A
Waitlist Available
Led By Philippe Demers, MD MSc
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admission for coronary artery bypass graft (CABG), valve replacement or valve repair surgery, or a combination of these surgeries;
Surgical procedure(s) on the ascending aorta and/or aortic arch that do not require deep hypothermic arrest (deep hypothermic arrest is defined as < 14° C);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at chest tube removal
Awards & highlights
ACT-POAF Trial Summary
The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Tube Clearance (ATC) technology in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to evaluate the impact of Active Tube Clearance (ATC) on other complications, such as retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or tamponade, and interventions for hemothorax, pericardial or pleural effusion.
Eligible Conditions
- Cardiac Tamponade
- Pericardial Effusion
- Atrial Fibrillation
- Pleural Effusion
- Hemothorax
ACT-POAF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACT-POAF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30-day post index surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30-day post index surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Postoperative Atrial Fibrillation
Secondary outcome measures
Number of Participants Presenting With a Chest Tube Occlusion
Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications)
Number of Participants Requiring Re-exploration for Bleeding or Tamponade
+2 moreOther outcome measures
Number of Patients Being Readmitted
Total Chest Tube Output
ACT-POAF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Active Tube Clearance drainageExperimental Treatment1 Intervention
The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space.
Group II: Standard drainageActive Control1 Intervention
The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Tube Clearance drainage
2015
N/A
~520
Find a Location
Who is running the clinical trial?
Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
68,299 Total Patients Enrolled
1 Trials studying Cardiac Tamponade
150 Patients Enrolled for Cardiac Tamponade
ClearFlow, Inc.Industry Sponsor
2 Previous Clinical Trials
2,004 Total Patients Enrolled
Hopital du Sacre-Coeur de MontrealOTHER
51 Previous Clinical Trials
11,749 Total Patients Enrolled
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