Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
PRINCE-CH is a multicentre, randomized controlled trial which evaluates the effectiveness and safety of posterior pericardiotomy in preventing POAF after cardiac surgery in Chinese population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than or equal to 18 years of age
Requiring surgical intervention on proximal aorta, cardiac valves, and/or coronary arteries
Able to provide informed consent
Disqualifiers
History of atrial fibrillation or flutter
Reoperations/minimally invasive cardiac surgery/emergent presentation
Need for hypothermic circulatory arrest
Disease of the left pleura or previous left thoracotomy
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, a 4-cm opening in the posterior pericardium will be made with a cautery between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the opening in pericardium with the tip into the left pleural space.
Treatment groups
650 Participants
are divided into 2 treatment groupsGroup A: Pericardiotomy GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative atrial fibrillation
Number of patients with postoperative atrial fibrillation within the 30 days postoperatively
Time frame
Within 30 days after index cardiac surgerySecondary outcomes
1
Atrial fibrillation burden
The proportion of time spent in atrial fibrillation during the total time of cardiac rhythm monitoring within 30 days after the operation, expressed as a percentage.
Time frame
Within 30 days after index cardiac surgery2
Heart rate variability
Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)
Time frame
within 30 days of index surgery3
Antiarrhythmic drug use
Number of patients received antiarrhythmic drug to control heart rhythm
Time frame
within 30 days of index surgery4
Electrical cardioversion
Number of patients received electrical cardioversion for severe heart arrhythmia
Time frame
within 30 days of index surgeryOther outcomes
1
Number of patients with cardiac tamponade
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 phrenic nerve 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.
Changhai Hospital
Lead sponsor
The General Hospital of Northern Theater Command
Collaborator
Source ClinicalTrials.gov