Clinical trial NCT06486636: Pericardiotomy in Cardiac Surgery
Official title: Pericardiotomy in Cardiac Surgery Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Cardiac Events
Keywords: Pericardiotomy
Cardiac Surgery
Hospital Readmission
Post-Operative Atrial Fibrillation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Hamilton Health Sciences Corporation
name: Weill Medical College of Cornell University
First posted: 2024-07-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will be assigned in a blinded fashion to one of two groups (left posterior pericardiotomy or no posterior pericardiotomy) in a 1:1 ratio.
Primary purpose: PREVENTION

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 trial's 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 visit/readmission 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Patient undergoing minimally invasive cardiac surgery

Primary outcomes:
measure: In-hospital post-operative atrial fibrillation
timeFrame: Within 5 days after index cardiac surgery
measure: Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
timeFrame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Secondary outcomes:
measure: Post-operative atrial fibrillation (POAF)
timeFrame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
measure: Length of post-operative in-hospital stay
timeFrame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
measure: Pericardial effusion without tamponade
timeFrame: From index surgery completion to within 30 days of index surgery
measure: Death
timeFrame: From index surgery completion to within 30 days of index surgery
measure: Ischemic stroke or systemic arterial embolism
timeFrame: From index surgery completion to within 30 days of index surgery
measure: Hospital readmission or unplanned hospital visit
timeFrame: From index surgery completion to within 30 days of index surgery
measure: Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire
timeFrame: Over the duration of the follow-up (mean follow-up of 5 years)
Other outcomes:
measure: Number of patients with phrenic nerve injuries
timeFrame: Within 30 days of index surgery
measure: Number of patients with left pleural interventions
timeFrame: Within 30 days of index surgery
measure: Number of patients with esophageal injuries
timeFrame: Within 30 days of index surgery
measure: Number of patients requiring re-operation for bleeding
timeFrame: Within 48 hours of index surgery completion
measure: Number of patients with cardiac tamponade
timeFrame: Within 30 days of index surgery
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Vienna
country: Austria
facility: Medical University Vienna
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Richard Whitlock
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Emilie Belley-Côté
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mario Gaudino
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Vienna
name: Sigrid Sandner
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborg University
name: Björn Redfors
role: PRINCIPAL_INVESTIGATOR
References: