RECRUITING

Pericardiotomy in Cardiac Surgery

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Conditions

Atrial FibrillationAtrial FlutterCardiac EventsPericardiotomyCardiac SurgeryHospital ReadmissionPost-Operative Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-10-21
Study Completion:2031-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06486636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients greater than or equal to 18 years of age
  2. * Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
  3. * Able to provide informed consent
  1. * History of atrial fibrillation or flutter
  2. * Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery)
  3. * Prior cardiac surgery requiring opening of the pericardium
  4. * Previous surgical instrumentation of the left pleural cavity
  5. * Patient undergoing minimally invasive cardiac surgery

Contacts and Locations

Study Contact

Richard Whitlock
CONTACT
9055274322
Richard.Whitlock@phri.ca
PRINCE Coordinators
CONTACT
PRINCE@phri.ca

Principal Investigator

Richard Whitlock
PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Emilie Belley-Côté
PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Mario Gaudino
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Sigrid Sandner
PRINCIPAL_INVESTIGATOR
Medical University Vienna
Björn Redfors
PRINCIPAL_INVESTIGATOR
Göteborg University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Population Health Research Institute

  • Richard Whitlock, PRINCIPAL_INVESTIGATOR, Population Health Research Institute
  • Emilie Belley-Côté, PRINCIPAL_INVESTIGATOR, Population Health Research Institute
  • Mario Gaudino, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Sigrid Sandner, PRINCIPAL_INVESTIGATOR, Medical University Vienna
  • Björn Redfors, PRINCIPAL_INVESTIGATOR, Göteborg University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2031-09-01

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2031-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Atrial Flutter
  • Cardiac Events