Atrial FibrillationNCT04947657
The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
An observational study of Atrial Fibrillation, run by Tulane University at 3 sites in United States.
Trial summary
The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2021to Dec 2027
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any AF patient who will undergo first time catheter ablation at Tulane University Medical Center and who is interested in the study will be able to contact the study coordinator for further screening. The investigators anticipate enrolling 20 patients to this study.
Who may be able to join
- Patients, male or female and older than 18 years of age.
- Patients diagnosed with persistent or paroxysmal AF.
- Patients that are undergoing catheter ablation at Tulane University Medical Center.
- Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.
Who cannot join
- Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc.
- Patients who are pregnant or breast-feeding or plan to become pregnant during the study period.
- Are not surgically sterile.
- Are of childbearing potential and are unwilling to practice two acceptable methods of birth control.
- Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).
- Patients with mental and/or physical ailments which may prohibit them from actively participating in the study.
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- Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.)
- Patients who have a known terminal illness with a prognosis less than 12 months at the time of the informed consent process.
- Planned cardiovascular intervention.
- Patient with diagnosed acute or chronic severe kidney disease or with a low glomerular filtration rate (GFR), <30 mL per minute per 1.73 m2
- Patients who cannot read, speak, and/or understand English.
- Patients with cognitive impairments who are unable 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
Mayana Bsoul, MD, 504-988-3063, mbsoul@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
Mayana Bsoul, MD, 504-988-3063, mbsoul@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
- Recruiting
Tulane Doctors - Speciality Care - Napoleon
New Orleans, Louisiana, 70115
Mayana Bsoul, MD, 504-988-3063, mbsoulmbsoul@tulane.edu
Kunal Sameer, MD, MHA, 504-988-3072, ksameer@tulane.edu
About this study
Official title: Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study
The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden.
Secondary objectives of the study are the following:
- To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.
- To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care.
- To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.
- To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.
Read the detailed description
COAG-AF is a 3-month prospective observational study in patients diagnosed with atrial fibrillation and undergoing a first-time ablation procedure. It will be a pilot study consisting of approximately twenty patients.
Patients will undergo a baseline blood draw prior to ablation. A cardiac MRI (LGE-MRI) scan will also be performed prior to ablation and is part of standard of care in patients undergoing ablation.
During catheter ablation, blood will be taken simultaneously from a peripheral blood vessel and from the left atrium (LA) at two different timepoints.
Patients will have additional blood draws immediately following ablation, one month and three months after ablation.
Study Data Elements:
The investigators will collect data from electronic medical health records and/or REDCap surveys sent through e-mail addresses provided by participants: demographic information, medical history, medication use, family history, and health behaviors (smoking, alcohol, eating habits etc.). Imaging data, notably echography and cardiac MRI will be recorded when applicable. Imaging data collected will include:
- LA fibrosis: %, and location.
- Left Ventricular (LV) fibrosis: % and location
- LA shape
- LA volume
- LA functional assessment
- Left ventricular ejection fraction (LVEF)
Chart reviews and surveys will collect the following data:
- All-cause mortality
- Cardiovascular mortality
- Hospitalizations
- Cerebrovascular events
- AF free interval after ablation
- Heart Failure
The investigators will also collect data from an FDA approved ElectroCardioGram (ECG) wearable patch (BodyGuardian® MINI) by Preventice, when prompted. All data elements will be stored on a secured, HIPAA compliant REDCap study database, only accessible by study team members.
Lab Tests:
Venipuncture will be performed by a trained nurse or a trained technician. Blood samples will be collected before ablation, twice during ablation, and after ablation at day 1, 30 and 90 at the Tulane Hospital blood laboratory. During ablation, two samples will be obtained from the LA simultaneously while obtaining peripheral blood. Note that the catheter is already in the LA while performing ablation. Therefore, no additional steps are required to obtain blood samples from LA.
Coagulation biomarkers that will be studied:
- Markers of endothelial dysfunction: Asymmetric dimethyl arginine (ADMA)
- Markers of platelet activation: P-selectin, Platelet factor 4, B-thromboglobulin
- Markers of coagulation: Von Willebrand factor (vWf), Thrombin levels: Thrombin Antithrombin levels (TAT), Prothrombin Factor 1+2, Fibrinogen levels, Factor 8, Factor 11
- Markers of fibrinolysis: D-dimers
ECG Wearable Patch:
Participants will receive an FDA approved BodyGuardian® MINI ECG patch provided by Preventice to wear post- ablation, as part of the patient's standard of care. Duration of ECG Patch will be determined by the treating physician. This will provide a continuous ECG strip to assess the amount of AF burden a patient is in after their procedure. The patch must be worn for the entire period and can be worn during exercise and during showering/bathing. A member of the clinical trial team will help with the application set-up process. They will assign each patient a unique identifier which will be entered into the device at the study site so that the patient's ECG transmissions will always be associated with their participant identifier (ID). These results will be uploaded onto the study data management platform for analysis.
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, Coagulation, Atrial Fibrillation burden
- Medical subject headings
- Atrial Fibrillation, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the change in Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between ADMA and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. ADMA will be measured in ng/mL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in markers of platelet activation P-selectin and Platelet factor 4 in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between the markers of platelet activation P-selectin and Platelet factor 4 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. P-selectin and Platelet factor 4 will be measured in ng/mL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in B-thromboglobulin in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between B-thromboglobulin and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. B-thromboglobulin will be measured in µg/L.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in coagulation marker Von Willebrand factor in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between coagulation marker Von Willebrand factor and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Von Willebrand factor will be measured in IU/dL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between Thrombin Antithrombin levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Thrombin Antithrombin levels will be measured in ng/ml.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in Prothrombin time (PT) in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between Prothrombin time and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. PT will be measured in seconds.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in Fibrinogen levels in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between Fibrinogen levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Fibrinogen levels will be measured in mg/dL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in Factor 8 in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between Factor 8 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 8 will be measured in Percent.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in Factor 11 in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between Factor 11 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 11 will be measured in U/dL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Measure the change in D-dimers in relation to atrial fibrillation burden
Blood samples will be collected from patients at different time points to measure the correlation between D-dimers and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. D-dimers will be measured in ng/mL.
Measured: Day 0, Day 1, Day 2, Day 30, Day 90
Secondary outcomes (10)
Determine the association between Asymmetric dimethyl arginine (ADMA) and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Asymmetric dimethyl arginine (ADMA). This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between P-selectin and Platelet factor 4 and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and P-selectin and Platelet factor 4. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Von Willebrand factor and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Von Willebrand factor. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between B-thromboglobulin and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and B-thromboglobulin. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Thrombin Antithrombin levels and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Thrombin Antithrombin levels. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Fibrinogen levels and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Fibrinogen levels. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Factor 8 and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Factor 8. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Factor 11 and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Factor 11. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between Prothrombin time (PT) and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and Prothrombin time (PT). This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Determine the association between D-dimers and degree of fibrosis in MRI findings
The investigators want to study the correlation between the degree of fibrosis found on Late Gadolinium Enhancement MRI (LGE-MRI) scans, which is a part of standard of care, and D-dimers. This will be obtained through the patient's medical history and charts.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start22 Sep 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947657
- Sponsor's protocol ID
- 2021-462
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu N, Tong S, Xiang Y, Wu L, Xu B, Zhang Y, Ma X, Li Y, Song Z, Zhong L. Association of hemostatic markers with atrial fibrillation: a meta-analysis and meta-regression. PLoS One. 2015 Apr 17;10(4):e0124716. doi: 10.1371/journal.pone.0124716. eCollection 2015.
PubMed 25884835Akar JG, Jeske W, Wilber DJ. Acute onset human atrial fibrillation is associated with local cardiac platelet activation and endothelial dysfunction. J Am Coll Cardiol. 2008 May 6;51(18):1790-3. doi: 10.1016/j.jacc.2007.11.083.
PubMed 18452786Lim HS, Willoughby SR, Schultz C, Gan C, Alasady M, Lau DH, Leong DP, Brooks AG, Young GD, Kistler PM, Kalman JM, Worthley MI, Sanders P. Effect of atrial fibrillation on atrial thrombogenesis in humans: impact of rate and rhythm. J Am Coll Cardiol. 2013 Feb 26;61(8):852-60. doi: 10.1016/j.jacc.2012.11.046. Epub 2013 Jan 16.
PubMed 23333141Ding WY, Gupta D, Lip GYH. Atrial fibrillation and the prothrombotic state: revisiting Virchow's triad in 2020. Heart. 2020 Oct;106(19):1463-1468. doi: 10.1136/heartjnl-2020-316977. Epub 2020 Jul 16.
PubMed 32675218Motoki H, Tomita T, Aizawa K, Kasai H, Izawa A, Kumazaki S, Tsutsui H, Koyama J, Ikeda U. Coagulation activity is increased in the left atria of patients with paroxysmal atrial fibrillation during the non-paroxysmal period. Comparison with chronic atrial fibrillation. Circ J. 2009 Aug;73(8):1403-7. doi: 10.1253/circj.cj-09-0008. Epub 2009 Jun 12.
PubMed 19521017Skov J, Sidelmann JJ, Bladbjerg EM, Jespersen J, Gram J. Lysability of fibrin clots is a potential new determinant of stroke risk in atrial fibrillation. Thromb Res. 2014 Sep;134(3):717-22. doi: 10.1016/j.thromres.2014.06.031. Epub 2014 Jul 5.
PubMed 25042725Katz DF, Maddox TM, Turakhia M, Gehi A, O'Brien EC, Lubitz SA, Turchin A, Doros G, Lei L, Varosy P, Marzec L, Hsu JC. Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment: Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry. Circ Cardiovasc Qual Outcomes. 2017 May;10(5):e003476. doi: 10.1161/CIRCOUTCOMES.116.003476.
PubMed 28506981Makowski M, Smorag I, Makowska J, Bissinger A, Grycewicz T, Pasnik J, Kidawa M, Lubinski A, Zielinska M, Baj Z. Platelet reactivity and mean platelet volume as risk markers of thrombogenesis in atrial fibrillation. Int J Cardiol. 2017 May 15;235:1-5. doi: 10.1016/j.ijcard.2017.03.023. Epub 2017 Mar 9.
PubMed 28302320Lip GY, Rumley A, Dunn FG, Lowe GD. Plasma fibrinogen and fibrin D-dimer in patients with atrial fibrillation: effects of cardioversion to sinus rhythm. Int J Cardiol. 1995 Oct;51(3):245-51. doi: 10.1016/0167-5273(95)02434-x.
PubMed 8586473Otto A, Fareed J, Liles J, Statz S, Walborn A, Rowe T, Jabati S, Hoppensteadt D, Syed MA. Fibrinolytic Deficit and Platelet Activation in Atrial Fibrillation and Their Postablation Modulation. Clin Appl Thromb Hemost. 2018 Jul;24(5):803-807. doi: 10.1177/1076029617750270. Epub 2018 Jan 28.
PubMed 29374968Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.
PubMed 19843914Van Gelder IC, Healey JS, Crijns HJGM, Wang J, Hohnloser SH, Gold MR, Capucci A, Lau CP, Morillo CA, Hobbelt AH, Rienstra M, Connolly SJ. Duration of device-detected subclinical atrial fibrillation and occurrence of stroke in ASSERT. Eur Heart J. 2017 May 1;38(17):1339-1344. doi: 10.1093/eurheartj/ehx042.
PubMed 28329139Negreva M, Zarkova A, Prodanova K, Petrov P. Paroxysmal Atrial Fibrillation: Insight Into the Intimate Mechanisms of Coagulation. Cardiol Res. 2020 Feb;11(1):22-32. doi: 10.14740/cr972. Epub 2020 Jan 26.
PubMed 32095193Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet. 2009 Jan 10;373(9658):155-66. doi: 10.1016/S0140-6736(09)60040-4.
PubMed 19135613
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study
- ClinicalTrials.gov ID
- NCT04947657
- Acronym / sponsor ID
- 2021-462
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, Coagulation, Atrial Fibrillation burden
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jul 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 aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden.
Secondary objectives of the study are the following:
- To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.
- To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care.
- To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.
- To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.
Detailed description
COAG-AF is a 3-month prospective observational study in patients diagnosed with atrial fibrillation and undergoing a first-time ablation procedure. It will be a pilot study consisting of approximately twenty patients.
Patients will undergo a baseline blood draw prior to ablation. A cardiac MRI (LGE-MRI) scan will also be performed prior to ablation and is part of standard of care in patients undergoing ablation.
During catheter ablation, blood will be taken simultaneously from a peripheral blood vessel and from the left atrium (LA) at two different timepoints.
Patients will have additional blood draws immediately following ablation, one month and three months after ablation.
Study Data Elements:
The investigators will collect data from electronic medical health records and/or REDCap surveys sent through e-mail addresses provided by participants: demographic information, medical history, medication use, family history, and health behaviors (smoking, alcohol, eating habits etc.). Imaging data, notably echography and cardiac MRI will be recorded when applicable. Imaging data collected will include:
- LA fibrosis: %, and location.
- Left Ventricular (LV) fibrosis: % and location
- LA shape
- LA volume
- LA functional assessment
- Left ventricular ejection fraction (LVEF)
Chart reviews and surveys will collect the following data:
- All-cause mortality
- Cardiovascular mortality
- Hospitalizations
- Cerebrovascular events
- AF free interval after ablation
- Heart Failure
The investigators will also collect data from an FDA approved ElectroCardioGram (ECG) wearable patch (BodyGuardian® MINI) by Preventice, when prompted. All data elements will be stored on a secured, HIPAA compliant REDCap study database, only accessible by study team members.
Lab Tests:
Venipuncture will be performed by a trained nurse or a trained technician. Blood samples will be collected before ablation, twice during ablation, and after ablation at day 1, 30 and 90 at the Tulane Hospital blood laboratory. During ablation, two samples will be obtained from the LA simultaneously while obtaining peripheral blood. Note that the catheter is already in the LA while performing ablation. Therefore, no additional steps are required to obtain blood samples from LA.
Coagulation biomarkers that will be studied:
- Markers of endothelial dysfunction: Asymmetric dimethyl arginine (ADMA)
- Markers of platelet activation: P-selectin, Platelet factor 4, B-thromboglobulin
- Markers of coagulation: Von Willebrand factor (vWf), Thrombin levels: Thrombin Antithrombin levels (TAT), Prothrombin Factor 1+2, Fibrinogen levels, Factor 8, Factor 11
- Markers of fibrinolysis: D-dimers
ECG Wearable Patch:
Participants will receive an FDA approved BodyGuardian® MINI ECG patch provided by Preventice to wear post- ablation, as part of the patient's standard of care. Duration of ECG Patch will be determined by the treating physician. This will provide a continuous ECG strip to assess the amount of AF burden a patient is in after their procedure. The patch must be worn for the entire period and can be worn during exercise and during showering/bathing. A member of the clinical trial team will help with the application set-up process. They will assign each patient a unique identifier which will be entered into the device at the study site so that the patient's ECG transmissions will always be associated with their participant identifier (ID). These results will be uploaded onto the study data management platform for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any AF patient who will undergo first time catheter ablation at Tulane University Medical Center and who is interested in the study will be able to contact the study coordinator for further screening. The investigators anticipate enrolling 20 patients to this study.
Key inclusion criteria (4 listed)
- Patients, male or female and older than 18 years of age.
- Patients diagnosed with persistent or paroxysmal AF.
- Patients that are undergoing catheter ablation at Tulane University Medical Center.
- Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.
Key exclusion criteria (12 listed)
- Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc.
- Patients who are pregnant or breast-feeding or plan to become pregnant during the study period.
- Are not surgically sterile.
- Are of childbearing potential and are unwilling to practice two acceptable methods of birth control.
- Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).
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
Measure the change in Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between ADMA and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. ADMA will be measured in ng/mL.
Measure the change in markers of platelet activation P-selectin and Platelet factor 4 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between the markers of platelet activation P-selectin and Platelet factor 4 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. P-selectin and Platelet factor 4 will be measured in ng/mL.
Measure the change in B-thromboglobulin in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between B-thromboglobulin and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. B-thromboglobulin will be measured in µg/L.
Measure the change in coagulation marker Von Willebrand factor in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between coagulation marker Von Willebrand factor and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Von Willebrand factor will be measured in IU/dL.
Measure the change in Thrombin Antithrombin levels in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Thrombin Antithrombin levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Thrombin Antithrombin levels will be measured in ng/ml.
Measure the change in Prothrombin time (PT) in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Prothrombin time and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. PT will be measured in seconds.
Measure the change in Fibrinogen levels in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Fibrinogen levels and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Fibrinogen levels will be measured in mg/dL.
Measure the change in Factor 8 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Factor 8 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 8 will be measured in Percent.
Measure the change in Factor 11 in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between Factor 11 and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. Factor 11 will be measured in U/dL.
Measure the change in D-dimers in relation to atrial fibrillation burden
Time frame: Day 0, Day 1, Day 2, Day 30, Day 90
Blood samples will be collected from patients at different time points to measure the correlation between D-dimers and the atrial fibrillation burden. One sample will be collected before the cardiac ablation at day 0, 2 samples will be collected during ablation at day 1, one sample at day 2, 1 sample at day 30, and one sample at day 90. Atrial fibrillation burden will be obtained from the patients charts review. D-dimers will be measured in ng/mL.
10 secondary outcomes
Determine the association between Asymmetric dimethyl arginine (ADMA) and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between P-selectin and Platelet factor 4 and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Von Willebrand factor and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between B-thromboglobulin and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Thrombin Antithrombin levels and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Fibrinogen levels and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Factor 8 and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Factor 11 and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between Prothrombin time (PT) and degree of fibrosis in MRI findings
Time frame: 1 Year
Determine the association between D-dimers and degree of fibrosis in MRI findings
Time frame: 1 Year
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 5 Mar 2026.
- Background: PubMed 25884835Wu N, Tong S, Xiang Y, Wu L, Xu B, Zhang Y, Ma X, Li Y, Song Z, Zhong L. Association of hemostatic markers with atrial fibrillation: a meta-analysis and meta-regression. PLoS One. 2015 Apr 17;10(4):e0124716. doi: 10.1371/journal.pone.0124716. eCollection 2015.
- Background: PubMed 18452786Akar JG, Jeske W, Wilber DJ. Acute onset human atrial fibrillation is associated with local cardiac platelet activation and endothelial dysfunction. J Am Coll Cardiol. 2008 May 6;51(18):1790-3. doi: 10.1016/j.jacc.2007.11.083.
- Background: PubMed 23333141Lim HS, Willoughby SR, Schultz C, Gan C, Alasady M, Lau DH, Leong DP, Brooks AG, Young GD, Kistler PM, Kalman JM, Worthley MI, Sanders P. Effect of atrial fibrillation on atrial thrombogenesis in humans: impact of rate and rhythm. J Am Coll Cardiol. 2013 Feb 26;61(8):852-60. doi: 10.1016/j.jacc.2012.11.046. Epub 2013 Jan 16.
- Background: PubMed 32675218Ding WY, Gupta D, Lip GYH. Atrial fibrillation and the prothrombotic state: revisiting Virchow's triad in 2020. Heart. 2020 Oct;106(19):1463-1468. doi: 10.1136/heartjnl-2020-316977. Epub 2020 Jul 16.
- Background: PubMed 19521017Motoki H, Tomita T, Aizawa K, Kasai H, Izawa A, Kumazaki S, Tsutsui H, Koyama J, Ikeda U. Coagulation activity is increased in the left atria of patients with paroxysmal atrial fibrillation during the non-paroxysmal period. Comparison with chronic atrial fibrillation. Circ J. 2009 Aug;73(8):1403-7. doi: 10.1253/circj.cj-09-0008. Epub 2009 Jun 12.
- Background: PubMed 25042725Skov J, Sidelmann JJ, Bladbjerg EM, Jespersen J, Gram J. Lysability of fibrin clots is a potential new determinant of stroke risk in atrial fibrillation. Thromb Res. 2014 Sep;134(3):717-22. doi: 10.1016/j.thromres.2014.06.031. Epub 2014 Jul 5.
- Background: PubMed 28506981Katz DF, Maddox TM, Turakhia M, Gehi A, O'Brien EC, Lubitz SA, Turchin A, Doros G, Lei L, Varosy P, Marzec L, Hsu JC. Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment: Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry. Circ Cardiovasc Qual Outcomes. 2017 May;10(5):e003476. doi: 10.1161/CIRCOUTCOMES.116.003476.
- Background: PubMed 28302320Makowski M, Smorag I, Makowska J, Bissinger A, Grycewicz T, Pasnik J, Kidawa M, Lubinski A, Zielinska M, Baj Z. Platelet reactivity and mean platelet volume as risk markers of thrombogenesis in atrial fibrillation. Int J Cardiol. 2017 May 15;235:1-5. doi: 10.1016/j.ijcard.2017.03.023. Epub 2017 Mar 9.
- Background: PubMed 8586473Lip GY, Rumley A, Dunn FG, Lowe GD. Plasma fibrinogen and fibrin D-dimer in patients with atrial fibrillation: effects of cardioversion to sinus rhythm. Int J Cardiol. 1995 Oct;51(3):245-51. doi: 10.1016/0167-5273(95)02434-x.
- Background: PubMed 29374968Otto A, Fareed J, Liles J, Statz S, Walborn A, Rowe T, Jabati S, Hoppensteadt D, Syed MA. Fibrinolytic Deficit and Platelet Activation in Atrial Fibrillation and Their Postablation Modulation. Clin Appl Thromb Hemost. 2018 Jul;24(5):803-807. doi: 10.1177/1076029617750270. Epub 2018 Jan 28.
- Background: PubMed 19843914Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.
- Background: PubMed 28329139Van Gelder IC, Healey JS, Crijns HJGM, Wang J, Hohnloser SH, Gold MR, Capucci A, Lau CP, Morillo CA, Hobbelt AH, Rienstra M, Connolly SJ. Duration of device-detected subclinical atrial fibrillation and occurrence of stroke in ASSERT. Eur Heart J. 2017 May 1;38(17):1339-1344. doi: 10.1093/eurheartj/ehx042.
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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.
Amitabh Pandey, 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, 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 4 inclusion and 12 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 5 Mar 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 Mayana Bsoul, MD (504-988-3063, mbsoul@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the change in Asymmetric dimethyl arginine (ADMA) in relation to atrial fibrillation burden (time frame: Day 0, Day 1, Day 2, Day 30, Day 90). The study lists 10 primary outcomes in all. 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 NCT04947657, 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 5 Mar 2026.