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Pericardiotomy in Cardiac Surgery

NCT06486636 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2025-07-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Richard Whitlock · Population Health Research Institute

  • Emilie Belley-Côté · Population Health Research Institute

  • Mario Gaudino · Weill Medical College of Cornell University

  • Sigrid Sandner · Medical University Vienna

  • Björn Redfors · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2027-09-01
Completion
2031-09-01

Countries

  • United States
  • Austria
  • Canada
  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486636 on ClinicalTrials.gov