Atrial Fibrillation Clinical Trial
Official title:
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study
Verified date | August 2023 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 520 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Admission for coronary artery bypass graft (CABG), valve replacement or valve repair surgery, or a combination of these surgeries; 2. Surgical procedure(s) on the ascending aorta and/or aortic arch that do not require deep hypothermic arrest (deep hypothermic arrest is defined as < 18° C); 3. Must be in sinus rhythm (SR) for a minimum of 30 days prior to the index surgery and at the start of the index surgery. No patient with history of atrial fibrillation. 4. Sign the institutional review board/institutional ethics committee approved informed consent form after the nature of the study has been explained and questions/concern have been addressed. Exclusion Criteria: 1. Admitted for surgical treatment of arrhythmia or Atrial fibrillation history; 2. Admitted for cardiac surgery requiring implantation/explantation of a Ventricular Assist Device (VAD) or heart transplant; 3. Admitted for Transcatheter aortic valve replacement (TAVR); 4. Cardiac surgical procedure that requires deep hypothermic arrest (as defined above); 5. New or active endocarditis or myocarditis that is not adequately controlled with medication and/or requires surgical intervention; 6. Documented inherited bleeding disorder(s);or 7. History or known allergies to the device materials. 8. Intervention carried out by a non-participating surgeon |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec |
Canada | Montreal Heart Institute | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute | ClearFlow, Inc., Hopital du Sacre-Coeur de Montreal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Patients Being Readmitted | Frequency of readmission for any indication | Within 30 days post index surgery | |
Other | Total Chest Tube Output | Total chest tube output (milliliter) | At chest tube removal | |
Primary | Number of Participants With Postoperative Atrial Fibrillation | Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode = 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge. | From post index surgery through hospital discharge, an average of 30 days | |
Secondary | Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications) | Any of the following:
Re-exploration for bleeding or cardiac tamponade Pericardial drainage procedure (pericardiocentesis or pericardial window) Pleural drainage procedure (thoracentesis, new chest tube, thoracoscopy or lateral thoracotomy) |
Within 30 days post index surgery | |
Secondary | Number of Participants Requiring Re-exploration for Bleeding or Tamponade | Rate of re-exploration for bleeding or tamponade within 30-day post index surgery | within 30-day post index surgery | |
Secondary | Number of Participants Presenting With a Chest Tube Occlusion | Visual observation of mediastinal chest tube lumen upon removal to determine whether it is:
patent partially occluded totally occluded |
At chest tube removal | |
Secondary | Number of Patients Requiring Pericardial Drainage Procedure | Rate of invasive pericardial drainage procedure within 30-day post index surgery | within 30-day post index surgery | |
Secondary | Number of Patients Requiring Pleural Drainage Procedure | Rate of invasive pleural drainage procedure within 30-day post index surgery | within 30-day post index surgery |
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