Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486636
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-13
Brief Title:
Pericardiotomy in Cardiac Surgery
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
Pericardiotomy in Cardiac Surgery Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRINCE
Brief Summary:
PRINCE is an international multicentre randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation AF or flutter undergoing cardiac surgery
Detailed Description:
Approximately 30 of cardiac surgical patients develop post-operative atrial fibrillation POAF Its incidence varies depending on the type of cardiac operation POAF is associated with short- and long-term adverse events including mortality stroke and heart failure POAF has also been significantly associated with unplanned hospitalization for heart failure
During cardiac surgery pericardial fluid tends to collect posterior to the left atrium Even small amounts of fluid may trigger atrial arrhythmias A posterior left pericardiotomy is a surgical procedure that involves cauterizing an opening between the left inferior pulmonary vein and the diaphragm This procedure may allow for more prolonged drainage of the pericardial fluid into the left pleural space Recent research evidence found that posterior pericardiotomy was associated with a significantly lower incidence of POAF
The existing data on posterior pericardiotomy is promising for a reduction in POAF However no high-quality study has demonstrated that this reduction improves clinical outcomes in the years after cardiac surgery The PRINCE trials long-term follow-up of patients randomized to left posterior pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable
The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of cardiac surgery patients
The intervention under investigation is left posterior pericardiotomy which is compared to no posterior pericardiotomy during cardiac surgery The early co-primary outcome is in-hospital POAF and the late co-primary outcome is the hierarchical composite of time to all-cause death time to ischemic stroke time to systemic arterial embolism time to unplanned hospital visitreadmission for cardiac reasons and time to atrial fibrillation after index hospital discharge
The study will enrol 1400 patients from 30 centres globally Follow-up visits will be performed in person or by telephone 1 and 6 months post-randomization 7 days and then every 6 months 30 days until an average follow-up of 5 years for the study participants estimated to be 4 years after completion of enrolment
During cardiac surgery pericardial fluid tends to collect posterior to the left atrium Even small amounts of fluid may trigger atrial arrhythmias A posterior left pericardiotomy is a surgical procedure that involves cauterizing an opening between the left inferior pulmonary vein and the diaphragm This procedure may allow for more prolonged drainage of the pericardial fluid into the left pleural space Recent research evidence found that posterior pericardiotomy was associated with a significantly lower incidence of POAF
The existing data on posterior pericardiotomy is promising for a reduction in POAF However no high-quality study has demonstrated that this reduction improves clinical outcomes in the years after cardiac surgery The PRINCE trials long-term follow-up of patients randomized to left posterior pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable
The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of cardiac surgery patients
The intervention under investigation is left posterior pericardiotomy which is compared to no posterior pericardiotomy during cardiac surgery The early co-primary outcome is in-hospital POAF and the late co-primary outcome is the hierarchical composite of time to all-cause death time to ischemic stroke time to systemic arterial embolism time to unplanned hospital visitreadmission for cardiac reasons and time to atrial fibrillation after index hospital discharge
The study will enrol 1400 patients from 30 centres globally Follow-up visits will be performed in person or by telephone 1 and 6 months post-randomization 7 days and then every 6 months 30 days until an average follow-up of 5 years for the study participants estimated to be 4 years after completion of enrolment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None