Prevention of Atrial Fibrillation After Cardiac Surgery by Posterior Pericardiotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
The goal of PREACT-AF is to learn if posterior pericardiotomy works to prevent the incidence of postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery.
The main questions it aims to answer are:
Does posterior pericardiotomy prevent the incidence of POAF for participants after cardiac surgery? What medical problems do participants have when undergoing posterior pericardiotomy?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients greater than or equal to 18 years of age
Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
Able to provide informed consent
Disqualifiers
History of atrial fibrillation or flutter
Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery)
Prior cardiac surgery requiring opening of the pericardium
Previous surgical instrumentation of the left pleural cavity
Trial design
Design model
Parallel
Treatments tested in this trial
Posterior Pericardiotomy
Procedure/SurgeryThe surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, the surgeon will use cautery to make a 4- to 5-cm opening in pericardium between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the posterior pericardium, the pericardiotomy and into the left pleural space.
Treatment groups
648 Participants
are divided into 2 treatment groupsGroup A: Posterior Pericardiotomy GroupExperimental treatment 1 intervention
Group B: No Posterior Pericardiotomy GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
In-hospital post-operative atrial fibrillation
Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first
Time frame
Within 5 days after index cardiac surgerySecondary outcomes
1
Length of post-operative in-hospital stay
Length of time the patient in hospital after their index cardiac surgery
Time frame
Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).2
Pericardial effusion without tamponade
Number of pericardial effusions that occur, excluding cardiac tamponade
Time frame
From index surgery completion to within 30 days of index surgery3
Death
Occurrence of death
Time frame
From index surgery completion to within 30 days of index surgery4
Ischemic stroke or systemic arterial embolism
Number of ischemic strokes or systemic arterial embolisms
Time frame
From index surgery completion to within 30 days of index surgeryOther outcomes
1
Number of patients with phrenic nerve injuries
Safety outcome
Time frame
Within 30 days of index surgery2
Number of patients with left pleural interventions
Safety outcome
Time frame
Within 30 days of index surgery3
Number of patients with esophageal injuries
Safety outcome
Time frame
Within 30 days of index surgery4
Number of patients requiring re-operation for bleeding
Safety outcome
Time frame
Within 48 hours of index surgery completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: