Skip to main content
OpenTrials
Completed

NCT Number: NCT02875405

The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery

The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weil Cornell Medical College Department of Cardiothoracic Surgery

New York, 10065, United States

About this study

Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.

Exclusion criteria

  • preoperative non-sinus rhythm
  • history of previous atrial arrhythmia of any type
  • reoperations
  • mitral or tricuspid valve disease
  • surgery of the descending thoracic or thoracoabdominal aorta
  • need for hypothermic circulatory arrest
  • off pump operation
  • urgent/emergent presentation
  • disease of the left pleura or previous left thoracotomy
  • chest deformity

Treatment and study plan

Posterior left pericardiotomy

Procedure

Patient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm.

Primary outcomes

  1. Number of participants that experience Postoperative Atrial Fibrillation (POAF)

    Time frame: During hospitalization, approximately 5 days

    POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.

Secondary outcomes

  1. Duration of Postoperative Atrial Fibrillation (POAF)

    Time frame: During hospitalization, approximately 5 days

    Time spent in atrial fibrillation (seconds), defined as the time from the first evidence of atrial fibrillation to the first evidence of sinus rhythm restoration on cardiac monitoring strips or standard electrocardiograms (EKG)

  2. Duration of Hospitalization

    Time frame: During hospitalization, up to 100 days after surgery

    Time (hours) spent in hospital after surgery completion

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Acronym: PALACS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2016
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.