Clinical trial Recruiting at 3 sites Observational Ages 40 to 120

Evaluating Atrial Fibrosis as a Predictor for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

Official title: Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF

Run by Tulane University · NCT05014802 · Data updated 2026-11-12

This study is trying to see if the amount of atrial fibrosis in patients can help predict if they will have heart rhythm problems after heart surgery.

Quick facts

Study typeObservational
Ages40 Years to 120 Years
SexAll
Enrollment50 (estimated)
SponsorTulane University
Academic / other
Locations3 sites (Covington, Louisiana and 2 other locations)
StatusRecruiting
StartedNovember 21, 2021
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJune 15, 2026
Trial IDNCT05014802 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 40 and older scheduled for cardiac surgery without a history of atrial arrhythmias.

Probably not a fit

Patients with a history of atrial arrhythmias or those under 40 years of age may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the relationship between baseline atrial fibrosis and the incidence of post-operative atrial fibrillation (POAF) in patients undergoing cardiac surgery. A total of 50 patients aged 40 and older, with no prior history of atrial arrhythmias, will undergo cardiac magnetic resonance imaging (MRI) to determine their Utah fibrosis stage. Following their surgeries, the incidence of atrial arrhythmias, in-hospital mortality, length of stay, and complication rates will be monitored and compared across different fibrosis stages. The study seeks to provide insights into how atrial fibrosis may influence surgical outcomes and healthcare costs.

Why it matters

Potential benefit: If successful, this study could help identify patients at higher risk for post-operative complications, allowing for better preoperative planning and management.

How similar studies have gone: While the specific approach of using baseline atrial fibrosis as a predictor for POAF is novel, related studies have explored the impact of atrial fibrosis on cardiac outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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)
* 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

Where it's running

  • Lakeview Hospital
    Covington, Louisiana, United States
    Recruiting
  • East Jefferson General Hospital
    New Orleans, Louisiana, United States
    Recruiting
  • Washington University Barnes-Jewish Hospital
    St Louis, Missouri, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.