Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT04814420

Conditions

Atrial Fibrillation

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Delayed enhancement magnetic resonance imaging (DE-MRI)

Study Details

Brief summary:

The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Obstructive Sleep Apnea

Study ID

NCT04814420

Start date

Jul 12, 2021

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Group A: 10 patients 18-75-year-old With mild OSA (5<AHI<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group B: 10 patients 18-75-year-old With moderate OSA (15<AHI<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group C: 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5<AHI<15), confirmed by polysomnography. Previous AF diagnosis

  • In this group, patients with AF and OSA who already have done MRI might be included.

Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. Previous AF diagnosis

\*In this group, patients with AF and OSA who already have done MRI might be included.

Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart

Exclusion Criteria:

  • History of chronic heart failure (LVEF < 50%), AF, myocardial infarction, valvular disease.
  • Prior cardiac or chest surgery.
  • Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.
  • Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate <30 ml/min, etc.).
  • Pregnancy.
  • Inability to give informed consent.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group A

Mild OSA

  • 10 patients diagnosed with mild OSA (5<AHI<15) with no atrial fibrillation.
  • Diagnosis confirmed through polysomnography\* before enrollment.

experimental: Group B

Moderate OSA

  • 10 patients diagnosed with moderate OSA (15<AHI<30) with no atrial fibrillation.
  • Diagnosis confirmed through polysomnography\* before enrollment.

experimental: Group C

Severe OSA

  • 10 patients diagnosed with severe OSA (AHI>30) with no atrial fibrillation.
  • Diagnosis confirmed through polysomnography\* before enrollment.

experimental: Group D

Mild OSA and AF

  • At least 10 patients diagnosed with mild OSA (5<AHI<15).
  • Diagnosis confirmed through polysomnography\* before enrollment.
  • Diagnosed with AF.

experimental: Group E

Severe OSA and AF

  • At least 10 patients diagnosed with severe OSA (AHI>30).
  • Diagnosis confirmed through polysomnography\* before enrollment.
  • Diagnosed with AF.

other: Group F

Control - No OSA

10 control patients without OSA and without AF.

Interventions

Delayed enhancement magnetic resonance imaging (DE-MRI)

The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.

Primary outcome measure

  • Percentage of atrial fibrosis in the left atrium measured by DE-MRI [ Time Frame: Baseline visit ]

Central Contacts and Locations

Central contacts

Christian Massad, MD

504-988-3072cmassad@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Locations

East Jefferson General Hospital

Recruiting

New Orleans, Louisiana, United States, 70006

Contacts

Christian Massad, MD

504-988-3072cmassad@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Amitabh Pandey, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Christian Massad, MD

504-988-3072cmassad@tulane.edu

Kunal Sameer, MS, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Amitabh Pandey, MD

Tulane Doctors - Speciality Care - Napoleon

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Christian Massad, MD

504-988-3072cmassad@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Siddharth Bhansali, MD

More Information

Sponsor

Tulane University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Ablation
  • Atrial Fibrosis
  • Delayed Enhancement Magnetic Resonance Imaging
  • Electrocardiogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-06-15.