Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT05014802

Conditions

Atrial Fibrillation

Atrial Arrhythmia

Atrial Flutter

Atrial Tachycardia

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Atrial Fibrillation

Atrial Arrhythmia

Atrial Flutter

Atrial Tachycardia

Study ID

NCT05014802

Start date

Nov 21, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Incidence of atrial arrhythmia in patients after cardiac surgery [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Yara Menassa, MD

504-316-2003ymenassa@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Locations

Lakeview Hospital

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Yara Menassa, MD

504-316-2003ymenassa@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Jamil Borgi, MD

East Jefferson General Hospital

Recruiting

New Orleans, Louisiana, United States, 70006

Contacts

Yara Menassa, MD

504-316-2003ymenassa@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Jamil Borgi, MD

Washington University Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Marci Damiano, RN, MSN

314-322-2545damianom@wustl.edu

Principal Investigator:

Ralph Damiano Jr., MD

More Information

Sponsor

Tulane University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Atrial Fibrosis
  • Cardiac Magnetic Resonance Imaging
  • Cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tulane University on 2026-06-15.