Atrial FibrillationNCT05014802
Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Tulane University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 120 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Arrhythmia, Atrial Flutter
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Nov 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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: * Approximately 10 Patients from either Tulane Medical Center and/or University Medical Center New Orleans. * Approximately 40 Patients from Washington University Medical Center (Barnes Jewish Hospital). 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.
Who may be able to join
- Male or female patients age 40 years of age or older
- Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair/reconstruction, aneurysm repair, and insertion of pacemaker).
Who cannot join
- Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)
- Patients with a history of cardiac or open chest surgery
- Patients with a history of catheter ablation
- Patients under the age of 40
- Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted
- Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)
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- Patients who have undergone or will undergo heart transplantation
- Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices/implants contraindicated for MRI)
- Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), <30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition).
- Patients weighing > 300 lbs. (MRI image quality decreases due to increased body mass index)
- Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period
- Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study
- Patients who cannot read, speak, and/or understand English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Lakeview Hospital
Covington, Louisiana, 70433
Yara Menassa, MD, 504-316-2003, ymenassa@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
East Jefferson General Hospital
New Orleans, Louisiana, 70006
Yara Menassa, MD, 504-316-2003, ymenassa@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
Washington University Barnes-Jewish Hospital
St Louis, Missouri, 63110
Marci Damiano, RN, MSN, 314-322-2545, damianom@wustl.edu
Ralph Damiano Jr., MD
About this study
Official title: Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF
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.
Read the detailed description
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.
- Keywords
- Atrial Fibrosis, Cardiac Magnetic Resonance Imaging, Cardiac surgery
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start21 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamil Borgi, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014802
- Sponsor's protocol ID
- 2021-622
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF
- ClinicalTrials.gov ID
- NCT05014802
- Acronym / sponsor ID
- 2021-622
- Keywords
- Atrial Fibrosis, Cardiac Magnetic Resonance Imaging, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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: * Approximately 10 Patients from either Tulane Medical Center and/or University Medical Center New Orleans. * Approximately 40 Patients from Washington University Medical Center (Barnes Jewish Hospital). 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.
Key inclusion criteria (2 listed)
- Male or female patients age 40 years of age or older
- Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair/reconstruction, aneurysm repair, and insertion of pacemaker).
Key exclusion criteria (13 listed)
- Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)
- Patients with a history of cardiac or open chest surgery
- Patients with a history of catheter ablation
- Patients under the age of 40
- Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of atrial arrhythmia in patients after cardiac surgery
Time frame: 2 weeks
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.
9 secondary outcomes
Rate of in-hospital mortality
Time frame: 2 weeks
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
Time frame: 2 weeks
Incidence of stroke
Time frame: 2 weeks
Incidence of acute respiratory failure
Time frame: 2 weeks
Incidence of sudden cardiac arrest
Time frame: 2 weeks
Incidence of shock
Time frame: 2 weeks
Incidence of systemic or pulmonary embolism
Time frame: 2 weeks
Incidence of infection post surgery
Time frame: 2 weeks
Hospitalization costs to the patient
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamil Borgi, MD principal investigator
Tulane University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Tulane University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Menassa, MD (504-316-2003, ymenassa@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial arrhythmia in patients after cardiac surgery (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.