Pericardiotomy in Cardiac Surgery
NCT Number: NCT06486636
Acronym: PRINCE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Atrial Flutter|Cardiac Events
Interventions: PROCEDURE: Left Posterior Pericardiotomy
Sponsor: Population Health Research Institute
Collaborators: McMaster University|Hamilton Health Sciences Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2031-09

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.

Primary Outcome Measures: 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, Within 5 days after index cardiac surgery|Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation., Number of patients with a composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation events, evaluated using the win ratio (thereby accounting for the difference in importance of these outcomes)., Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Secondary Outcome Measures: Post-operative atrial fibrillation (POAF), Number of patients with post-operative atrial fibrillation, Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).|Length of post-operative in-hospital stay, Length of time the patient in hospital after their index cardiac surgery, Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).|Pericardial effusion without tamponade, Number of pericardial effusions that occur, excluding cardiac tamponade, From index surgery completion to within 30 days of index surgery|Death, Occurrence of death, From index surgery completion to within 30 days of index surgery|Ischemic stroke or systemic arterial embolism, Number of ischemic strokes or systemic arterial embolisms, From index surgery completion to within 30 days of index surgery|Hospital readmission or unplanned hospital visit, Number of hospital readmissions or unplanned hospital visits, From index surgery completion to within 30 days of index surgery|Quality of life assessed by the Short Form 12 (SF-12) Health Survey, The Short Form 12 (SF-12) Health Survey is a patient-reported outcome measure collected via a 12-question survey which is scored by a clinician or researcher. The scoring process yields a Physical Component Summary (PCS) and the Mental Component Summary (MCS). Patients answer questions on either a 5 point or 3 point scale, depending on the question. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. The eight domains assessed in the survey are: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, and general health perceptions., Over the duration of the follow-up (mean follow-up of 5 years)|Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire, The EQ-5D-5L consists of a descriptive system and the EQ visual analogue scale (EQ VAS) scale of 0-100 where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured on a 5 point scale: no problems, slight problems, moderate problems, severe problems and extreme problems., Over the duration of the follow-up (mean follow-up of 5 years)
Other Outcome Measures: Number of patients with phrenic nerve injuries, Safety outcome, Within 30 days of index surgery|Number of patients with left pleural interventions, Safety outcome, Within 30 days of index surgery|Number of patients with esophageal injuries, Safety outcome, Within 30 days of index surgery|Number of patients requiring re-operation for bleeding, Safety outcome, Within 48 hours of index surgery completion|Number of patients with cardiac tamponade, Safety outcome, Within 30 days of index surgery