Pericardiotomy in Cardiac Surgery

NCT06486636 | Recruiting DMC

• 1 other identifier: PRINCE - 2024
• Study Type: interventional
• Target: 1,400
• Locations: 4 countries
• Sites: 4

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.

Conditions

Atrial Fibrillation; Atrial Flutter; Cardiac Events

Keywords

Pericardiotomy; Cardiac Surgery; Hospital Readmission; Post-Operative Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Post-operative atrial fibrillation (POAF)

  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

  Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).

• Pericardial effusion without tamponade

  From index surgery completion to within 30 days of index surgery

• Death

  From index surgery completion to within 30 days of index surgery

• Ischemic stroke or systemic arterial embolism

  From index surgery completion to within 30 days of index surgery

Other Outcomes (5)

• Number of patients with phrenic nerve injuries

  Within 30 days of index surgery

• Number of patients with left pleural interventions

  Within 30 days of index surgery

• Number of patients with esophageal injuries

  Within 30 days of index surgery

Study Arms (2)

Left Posterior Pericardiotomy Group

EXPERIMENTAL

The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery.

Procedure: Left Posterior Pericardiotomy

No Posterior Pericardiotomy Group

NO INTERVENTION

The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.

Interventions

Left Posterior Pericardiotomy PROCEDURE

The surgeon will perform a left posterior pericardiotomy while the patient is on cardiopulmonary bypass. A soft channel drain will be put into place at an angle directed toward the posterior pericardium. The surgeon will grasp the pericardium and use cautery to make a 4- to 5-cm opening between the left inferior pulmonary vein and the diaphragm. The previously prepared channel drain is cut to the desired length and placed through the pericardiotomy along the diaphragm and into the pleural space.

Left Posterior Pericardiotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of atrial fibrillation or flutter
• Prior cardiac surgery requiring opening of the pericardium
• Previous surgical instrumentation of the left pleural cavity
• Patient undergoing minimally invasive cardiac surgery

Sponsors & Collaborators

• Population Health Research Institute: lead
• McMaster University: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (4)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

University of Foggia, Policlinico Foggia

Foggia, Foggia, 71122, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Whitlock

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Emilie Belley-Côté

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Mario Gaudino

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Sigrid Sandner

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Björn Redfors

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Whitlock

CONTACT

9055274322; Richard.Whitlock@phri.ca

PRINCE Coordinators

CONTACT

PRINCE@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to allocation will be maintained for all parties, excluding the operating surgeon and necessary operating room personnel.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 3, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

AU (1); CA (1); IT (1); US (1)