RecruitingNot ApplicableNCT06486636

Pericardiotomy in Cardiac Surgery

Pericardiotomy in Cardiac Surgery Trial


Sponsor

Population Health Research Institute

Enrollment

1,400 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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
  • Prior cardiac surgery requiring opening of the pericardium
  • Previous surgical instrumentation of the left pleural cavity
  • Patient undergoing minimally invasive cardiac surgery

Exclusion Criteria1

  • History of atrial fibrillation or flutter

Interventions

PROCEDURELeft 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.


Locations(4)

Weill Cornell Medicine

New York, New York, United States

Medical University Vienna

Vienna, Vienna, Austria

Hamilton Health Sciences

Hamilton, Ontario, Canada

University of Foggia, Policlinico Foggia

Foggia, Foggia, Italy

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NCT06486636


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