Recruiting

PericardiotomyPericardiotomy in Cardiac Surgery

Sponsor:

Population Health Research Institute

Code:

NCT06486636

Conditions

Atrial Fibrillation

Atrial Flutter

Cardiac Events

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Left Posterior Pericardiotomy

Study Details

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

Study ID

NCT06486636

Start date

Oct 21, 2024

Status verified date

Jul, 2025

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Left Posterior Pericardiotomy Group

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

no intervention: No Posterior Pericardiotomy Group

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

Interventions

Left Posterior Pericardiotomy

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.

Primary outcome measure

In-hospital post-operative atrial fibrillation [ Time Frame: 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. [ Time Frame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years). ]

Central Contacts and Locations

Central contacts

Richard Whitlock

9055274322 Richard.Whitlock@phri.ca

PRINCE Coordinators

PRINCE@phri.ca

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Dr. Mario Gaudino, MD, PhD

212-746-1815 mfg9004@med.cornell.edu

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Emilie Belley-Côté, MD, PhD, FRCPC

(905) 527-4322 Emilie.Belley-Cote@phri.ca

More Information

Sponsor

Population Health Research Institute

Last update posted

Jul 14, 2025

Last verified

Jul, 2025

Keywords

Pericardiotomy
Cardiac Surgery
Hospital Readmission
Post-Operative Atrial Fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-07-14.