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RECRUITING
NCT06486636
NA

Pericardiotomy in Cardiac Surgery

Sponsor: Population Health Research Institute

View on ClinicalTrials.gov

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.

Official title: Pericardiotomy in Cardiac Surgery Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2024-10-21

Completion Date

2031-09-01

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

PROCEDURE

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.

Locations (19)

University of Louisville

Louisville, Kentucky, United States

Weill Cornell Medicine

New York, New York, United States

Baylor College of Medicine

Houston, Texas, United States

Medical University Vienna

Vienna, State of Vienna, Austria

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Nova Scotia Health Authority - Halifax Infirmary

Halifax, Nova Scotia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

(CHUM) Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

McGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, Canada

Hôpital du Sacré-Cœur-de-Montréal

Montreal, Quebec, Canada

Policlinico Foggia

Foggia, Foggia, Italy

University of Foggia, Policlinico Foggia

Foggia, Foggia, Italy

IRCSS Policlinico San Donato

San Donato Milanese, Milano, Italy

Maria Pia Hospital

Turin, Turin, Italy

San Bortolo Hospital

Vicenza, Vincenza, Italy

Hospital Universitario del Vinalopo

Alicante, Alicante, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain