An observational study in Atrial Fibrillation, Atrial Arrhythmia and Atrial Flutter, sponsored by Tulane University. Recruiting at 3 sites in United States. Open to participants aged 40 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Tulane University · Observational
The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.
The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.
The study is a a prospective, observational cohort study. 50 patients undergoing cardiac surgery (Coronary Artery Bypass Graft (CABG), valvular etc.) without a history of atrial fibrillation will be given a baseline Magnetic Resonance Imaging (MRI) upon which patients will be assigned Utah stages I-IV based on their left atrial fibrosis pattern. Overall fibrosis (%) of the left atrial wall area will also be collected. Patients will then undergo their planned surgeries receiving management adherent to current guidelines and standard of care procedures. Atrial arrhythmia incidence after surgical procedure will be collected using in-hospital telemetry or serial Electrocardiogram (ECG) from all patients in their respective cohorts. Cardiac surgery type, duration and any intraoperative complications will be recorded. Other clinical and relevant demographical data will be collected at admission and throughout patients' hospital stay.
All cardiac surgeries will be performed by experienced surgeons at Tulane Medical Center, Washington University Medical Center Barnes Jewish Hospital, and University Medical Center New Orleans, adhering to all relevant standard-of-care guidelines. MRI imaging will be performed by experienced technicians and operators at Tulane Medical Center, Washington University Medical Center Barnes Jewish Hospital, and University Medical Center New Orleans. MRI Utah fibrosis staging will be performed and assessed by experienced operators at MARREK, Inc., by using the Corview processing software with de-identified images.
The investigators expect a total recruitment of 50 subjects over a period of 6 months from the Tulane Medical Center Cardiology and Cardiothoracic Surgery Clinics, Washington University Medical Center Barnes Jewish Hospital Cardiology and Cardiothoracic Surgery Clinics, as well as University Medical Center New Orleans Cardiology and Cardiothoracic Surgery Clinics in order to complete the study. They expect to recruit 40 patients from Washington University Medical Center and 10 patients from either Tulane Medical Center or University Medical Center New Orleans.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 50 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population is any patient with no history of atrial arrhythmia scheduled to undergo cardiac surgery and meets other inclusion/exclusion criteria).
Each Site:
The PIs and co-PI will have access to recruit patients through their cardiology and cardiothoracic surgery clinics.
Participants may also be recruited from the community by direct advertising; emails, TV, flyers posted in public places, as well as online postings to study-site affiliated websites, social media platforms (Facebook, Twitter, Instagram) and LinkedIn.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Incidence of atrial arrhythmia in patients after cardiac surgery
The incidence of any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia etc.) from after their surgical procedure to their discharge from the hospital. Atrial arrhythmia is defined as any abnormal atrial rhythm episode continuing for more than 30 seconds, starting immediately after the patient arrives at the post-operation ICU. All atrial arrhythmia starting after the operation will be monitored and recorded. This will be measured using continuous telemetry and/or serial ECG monitoring.
Time frame: 2 weeks
Rate of in-hospital mortality
In-hospital mortality is defined as patient death during any point of hospital stay following cardiac surgery. This will be measured through patients medical chart review.
Time frame: 2 weeks
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
LOS is defined as duration from admission to discharge in days in the hospital and ICU. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of stroke
Stroke is defined as sudden loss of brain function caused by an interruption of blood supply to the brain either through an ischemic or hemorrhagic modality. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of acute respiratory failure
Acute respiratory failure is any decrease in respiratory function resulting in hypoxemia (low arterial oxygen levels), hypercapnia (elevated levels of carbon dioxide gas) or a combination of the two. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of sudden cardiac arrest
Sudden cardiac arrest is the abrupt loss of heart function, breathing and consciousness. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of shock
Shock is a critical condition brought on by the sudden drop in blood flow through the body. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of systemic or pulmonary embolism
An embolus is a blood clot that forms in the systemic or pulmonary circulation that jeopardizes normal blood flow to the area causing organ dysfunction. This will be measured through patients medical chart review.
Time frame: 2 weeks
Incidence of infection post surgery
Infection is the invasion and multiplication of microorganisms in any area of the body, specifically the heart, lungs, blood and gastrointestinal and urinary tract. This will be measured through patients medical chart review.
Time frame: 2 weeks
Hospitalization costs to the patient
All costs related to the current episode of hospitalization including procedures, medication, personnel and machine time, calculated prior to insurance or Medicaid/Medicare discount. This will be obtained through hospital billing department.
Time frame: 2 weeks
Started Nov 2021 (actual). Primary completion is estimated for Dec 2026, 61 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 61 months is above that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Tulane University