Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, 10065, United States
NCT Number: NCT02875405
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10065, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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)
Time frame: During hospitalization, up to 100 days after surgery
Time (hours) spent in hospital after surgery completion
Weill Medical College of Cornell University
Other
Acronym: PALACS
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