Atrial FibrillationNCT04814420
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
A study testing Delayed enhancement magnetic resonance imaging (DE-MRI) in people with Atrial Fibrillation and Obstructive Sleep Apnea, run by Tulane University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea
- What is being tested?
- Delayed enhancement magnetic resonance imaging (DE-MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jul 2021to Nov 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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
East Jefferson General Hospital
New Orleans, Louisiana, 70006
Christian Massad, MD, 504-988-3072, cmassad@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
Christian Massad, MD, 504-988-3072, cmassad@tulane.edu
Kunal Sameer, MS, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
Tulane Doctors - Speciality Care - Napoleon
New Orleans, Louisiana, 70115
Christian Massad, MD, 504-988-3072, cmassad@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
About this study
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).
Read the detailed description
This is a cross sectional pilot study. Sixty mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Being tested
- Delayed enhancement magnetic resonance imaging (DE-MRI)
- Keywords
- Ablation, Atrial Fibrosis, Delayed Enhancement Magnetic Resonance Imaging, Electrocardiogram
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed enhancement magnetic resonance imaging (DE-MRI)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Mild OSA
* 10 patients diagnosed with mild OSA (5<AHI<15) with no atrial fibrillation.
* Diagnosis confirmed through polysomnography* before enrollment. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
| Group B | Experimental | Moderate OSA
* 10 patients diagnosed with moderate OSA (15<AHI<30) with no atrial fibrillation.
* Diagnosis confirmed through polysomnography* before enrollment. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
| Group C | Experimental | Severe OSA
* 10 patients diagnosed with severe OSA (AHI>30) with no atrial fibrillation.
* Diagnosis confirmed through polysomnography* before enrollment. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
| Group D | Experimental | Mild OSA and AF
* At least 10 patients diagnosed with mild OSA (5<AHI<15).
* Diagnosis confirmed through polysomnography* before enrollment.
* Diagnosed with AF. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
| Group E | Experimental | Severe OSA and AF
* At least 10 patients diagnosed with severe OSA (AHI>30).
* Diagnosis confirmed through polysomnography* before enrollment.
* Diagnosed with AF. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
| Group F | Other | Control - No OSA
10 control patients without OSA and without AF. Receives: Device: Delayed enhancement magnetic resonance imaging (DE-MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of atrial fibrosis in the left atrium measured by DE-MRI
DE-MRI purpose is to quantify the degree of atrial structural remodeling or fibrosis Left Atrial Volume Max on MRI measurement reflects atrial load to provide insight into atrial remodeling Left Atrial Volume Min on MRI is important for understanding atrial function, particularly its ability to contract and expel blood into left ventricle Left Atrial Volume Index on MRI is an indicator of left atrial enlargement compared to raw volume measurements Left Atrial Emptying Fraction on MRI is a measure of atrial contractile function. Higher LAEF indicates better atrial function, while lower values can signal impaired atrial mechanics Left Atrial Global Strain on MRI which is the percentage change in myocardial length along the long axis of the left atrium, is calculated using a formula averaging the individual longitudinal strain values from each segment of the myocardium, providing a comprehensive measure of myocardial deformation
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start12 Jul 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Sixty participants would be an adequate sample size for this pilot study to represent all stages of OSA and controls (10 mild, 10 moderate,10 severe OSA with no atrial fibrillation, 10 controls with no OSA and no atrial fibrillation, 10 mild and 10 severe OSA with atrial fibrillation).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitabh Pandey, MD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814420
- Sponsor's protocol ID
- 2019-2081
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
May AM, Van Wagoner DR, Mehra R. OSA and Cardiac Arrhythmogenesis: Mechanistic Insights. Chest. 2017 Jan;151(1):225-241. doi: 10.1016/j.chest.2016.09.014. Epub 2016 Sep 29.
PubMed 27693594Gami AS, Hodge DO, Herges RM, Olson EJ, Nykodym J, Kara T, Somers VK. Obstructive sleep apnea, obesity, and the risk of incident atrial fibrillation. J Am Coll Cardiol. 2007 Feb 6;49(5):565-71. doi: 10.1016/j.jacc.2006.08.060. Epub 2007 Jan 22.
PubMed 17276180Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.
PubMed 15249509Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.
PubMed 12743002Ng CY, Liu T, Shehata M, Stevens S, Chugh SS, Wang X. Meta-analysis of obstructive sleep apnea as predictor of atrial fibrillation recurrence after catheter ablation. Am J Cardiol. 2011 Jul 1;108(1):47-51. doi: 10.1016/j.amjcard.2011.02.343. Epub 2011 Apr 29.
PubMed 21529734Linz D, Brooks AG, Elliott AD, Nalliah CJ, Hendriks JML, Middeldorp ME, Gallagher C, Mahajan R, Kalman JM, McEvoy RD, Lau DH, Sanders P. Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701. doi: 10.1016/j.jacep.2019.03.005. Epub 2019 May 1.
PubMed 31221356Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.
PubMed 19307477Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
PubMed 24496537Gal P, Marrouche NF. Magnetic resonance imaging of atrial fibrosis: redefining atrial fibrillation to a syndrome. Eur Heart J. 2017 Jan 1;38(1):14-19. doi: 10.1093/eurheartj/ehv514. Epub 2015 Sep 25.
PubMed 26409008King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.
PubMed 28882227Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.
PubMed 17478161Dimitri H, Ng M, Brooks AG, Kuklik P, Stiles MK, Lau DH, Antic N, Thornton A, Saint DA, McEvoy D, Antic R, Kalman JM, Sanders P. Atrial remodeling in obstructive sleep apnea: implications for atrial fibrillation. Heart Rhythm. 2012 Mar;9(3):321-7. doi: 10.1016/j.hrthm.2011.10.017. Epub 2011 Oct 19.
PubMed 22016075Anter E, Di Biase L, Contreras-Valdes FM, Gianni C, Mohanty S, Tschabrunn CM, Viles-Gonzalez JF, Leshem E, Buxton AE, Kulbak G, Halaby RN, Zimetbaum PJ, Waks JW, Thomas RJ, Natale A, Josephson ME. Atrial Substrate and Triggers of Paroxysmal Atrial Fibrillation in Patients With Obstructive Sleep Apnea. Circ Arrhythm Electrophysiol. 2017 Nov;10(11):e005407. doi: 10.1161/CIRCEP.117.005407.
PubMed 29133380Iwasaki YK, Kato T, Xiong F, Shi YF, Naud P, Maguy A, Mizuno K, Tardif JC, Comtois P, Nattel S. Atrial fibrillation promotion with long-term repetitive obstructive sleep apnea in a rat model. J Am Coll Cardiol. 2014 Nov 11;64(19):2013-23. doi: 10.1016/j.jacc.2014.05.077. Epub 2014 Nov 3.
PubMed 25440097
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
- Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04814420
- Acronym / sponsor ID
- 2019-2081
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Keywords
- Ablation, Atrial Fibrosis, Delayed Enhancement Magnetic Resonance Imaging, Electrocardiogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Mar 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 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).
Detailed description
This is a cross sectional pilot study. Sixty mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sixty participants would be an adequate sample size for this pilot study to represent all stages of OSA and controls (10 mild, 10 moderate,10 severe OSA with no atrial fibrillation, 10 controls with no OSA and no atrial fibrillation, 10 mild and 10 severe OSA with atrial fibrillation).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Mild OSA * 10 patients diagnosed with mild OSA (5<AHI<15) with no atrial fibrillation. * Diagnosis confirmed through polysomnography* before enrollment. |
| Group B | Experimental | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Moderate OSA * 10 patients diagnosed with moderate OSA (15<AHI<30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography* before enrollment. |
| Group C | Experimental | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Severe OSA * 10 patients diagnosed with severe OSA (AHI>30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography* before enrollment. |
| Group D | Experimental | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Mild OSA and AF * At least 10 patients diagnosed with mild OSA (5<AHI<15). * Diagnosis confirmed through polysomnography* before enrollment. * Diagnosed with AF. |
| Group E | Experimental | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Severe OSA and AF * At least 10 patients diagnosed with severe OSA (AHI>30). * Diagnosis confirmed through polysomnography* before enrollment. * Diagnosed with AF. |
| Group F | Other | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)Control - No OSA 10 control patients without OSA and without AF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
Percentage of atrial fibrosis in the left atrium measured by DE-MRI
Time frame: Baseline visit
DE-MRI purpose is to quantify the degree of atrial structural remodeling or fibrosis Left Atrial Volume Max on MRI measurement reflects atrial load to provide insight into atrial remodeling Left Atrial Volume Min on MRI is important for understanding atrial function, particularly its ability to contract and expel blood into left ventricle Left Atrial Volume Index on MRI is an indicator of left atrial enlargement compared to raw volume measurements Left Atrial Emptying Fraction on MRI is a measure of atrial contractile function. Higher LAEF indicates better atrial function, while lower values can signal impaired atrial mechanics Left Atrial Global Strain on MRI which is the percentage change in myocardial length along the long axis of the left atrium, is calculated using a formula averaging the individual longitudinal strain values from each segment of the myocardium, providing a comprehensive measure of myocardial deformation
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.
- Background: PubMed 27693594May AM, Van Wagoner DR, Mehra R. OSA and Cardiac Arrhythmogenesis: Mechanistic Insights. Chest. 2017 Jan;151(1):225-241. doi: 10.1016/j.chest.2016.09.014. Epub 2016 Sep 29.
- Background: PubMed 17276180Gami AS, Hodge DO, Herges RM, Olson EJ, Nykodym J, Kara T, Somers VK. Obstructive sleep apnea, obesity, and the risk of incident atrial fibrillation. J Am Coll Cardiol. 2007 Feb 6;49(5):565-71. doi: 10.1016/j.jacc.2006.08.060. Epub 2007 Jan 22.
- Background: PubMed 15249509Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12.
- Background: PubMed 12743002Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.
- Background: PubMed 21529734Ng CY, Liu T, Shehata M, Stevens S, Chugh SS, Wang X. Meta-analysis of obstructive sleep apnea as predictor of atrial fibrillation recurrence after catheter ablation. Am J Cardiol. 2011 Jul 1;108(1):47-51. doi: 10.1016/j.amjcard.2011.02.343. Epub 2011 Apr 29.
- Background: PubMed 31221356Linz D, Brooks AG, Elliott AD, Nalliah CJ, Hendriks JML, Middeldorp ME, Gallagher C, Mahajan R, Kalman JM, McEvoy RD, Lau DH, Sanders P. Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701. doi: 10.1016/j.jacep.2019.03.005. Epub 2019 May 1.
- Background: PubMed 19307477Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.
- Background: PubMed 24496537Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
- Background: PubMed 26409008Gal P, Marrouche NF. Magnetic resonance imaging of atrial fibrosis: redefining atrial fibrillation to a syndrome. Eur Heart J. 2017 Jan 1;38(1):14-19. doi: 10.1093/eurheartj/ehv514. Epub 2015 Sep 25.
- Background: PubMed 28882227King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.
- Background: PubMed 17478161Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.
- Background: PubMed 22016075Dimitri H, Ng M, Brooks AG, Kuklik P, Stiles MK, Lau DH, Antic N, Thornton A, Saint DA, McEvoy D, Antic R, Kalman JM, Sanders P. Atrial remodeling in obstructive sleep apnea: implications for atrial fibrillation. Heart Rhythm. 2012 Mar;9(3):321-7. doi: 10.1016/j.hrthm.2011.10.017. Epub 2011 Oct 19.
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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.
Amitabh Pandey, MD principal investigator
Tulane University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed enhancement magnetic resonance imaging (DE-MRI) in people with Atrial Fibrillation and Obstructive Sleep Apnea, 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 8 inclusion and 6 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 Christian Massad, MD (504-988-3072, cmassad@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of atrial fibrosis in the left atrium measured by DE-MRI (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814420, which also lists 14 linked publications.
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.