Atrial FibrillationAFCOGNCT04033510
Acute Cognitive Changes During Atrial Fibrillation Episodes (AFCOG)
An observational study of Atrial Fibrillation and Cognitive Symptom, run by David Brunk, PA-C, MMS at 1 site in United States.
Trial summary
Objectives: First, to determine if patients with a history of AF have acute measurable changes in cognitive functioning while in an episode of AF. Second, to collect basic insight into what specific physiologic (blood pressure, pulse oximetry, heart rate, temperature) and pharmacologic (antiarrhythmic medications… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Cognitive Symptom, Executive Dysfunction
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 30 Jan 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 35 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients of Colorado Springs Cardiology: A Centura Health Clinic (CSC) with a history of, or new diagnosis of, Atrial fibrillation with the intention of being converted back to normal rhythm.
Who may be able to join
- Subjects who are patients at CSC or Penrose-St. Francis Health Services.
- Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to normal rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).
- Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.
Who cannot join
- Patients who had coronary bypass surgery during their life time.
- Patients with a previously documented history of post-pump syndrome during their life time.
- Patients with presence of, or medical diagnosis of Transient Ischemic Attack (TIA) or Cerebral Vascular Accident (CVA).
- Patients with presence of, or medical diagnosis of cognitive impairment (dementia, multiple sclerosis, traumatic brain injury, etc.).
- Female patients who are pregnant or post-partum.
- Individuals unwilling or unable to take an anticoagulant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penrose St. Francis
Colorado Springs, Colorado, 80907
About this study
Objectives:
- First, to determine if patients with a history of AF have acute measurable changes in cognitive functioning while in an episode of AF.
- Second, to collect basic insight into what specific physiologic (blood pressure, pulse oximetry, heart rate, temperature) and pharmacologic (antiarrhythmic medications, rate control medications, anticoagulants, antiplatelet medications, etc.) factors minimize the neurological impact on patients while they are in AF.
It is hypothesized that when using a tablet-based cognitive testing software - Cambridge Cognition (specifically to assess executive function, learning and working memory: Rapid Visual Information Processing test, Spatial Working Memory/Spatial Span Task tests, One touch Stockings of Cambridge test, Cambridge Gambling Task, Multitasking Test/Intra-Extra Dimensional Set shift tests) - a significant difference will be noted between how the patients perform while in atrial fibrillation compared to the patients' performance while in normal sinus rhythm.
Read the detailed description
Inclusion Criteria
- Subjects who are patients at Colorado Springs Cardiology (CSC) or Penrose-St. Francis Health Services.
- Patients who are between 35-80 years of age.
- Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to sinus rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).
- Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.
Method of Recruitment
- Study participants will be recruited after it is determined that they are acutely in an episode of AF by a standard of care 12-lead EKG (or KardiaApp), during an outpatient clinical visit (established patient clinical visits, consultations, or new patient visits) at CSC, or when being consulted on or rounded on at Penrose Hospital or St. Francis Medical Center.
- A baseline 12 lead EKG (or KardiaApp) at recruitment will establish or confirm the presence of AF
- The research personnel will review the consent for the study with the patient while they are in the CSC office or the patient's room if they are recruited during their time admitted to Penrose-St. Francis Health Services. After the patient has signed the consent, patient eligibility will be confirmed and the study process will continue.
Patients may also be phone consented and complete the testing at home via web-based testing.
- Patients of CSC with a known history of AF with be contacted with information on the study. If the patient is interested and have had >3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study with the intention of having the subject already enrolled in the study before their next episode of AF.
Procedure:
The study involves an observational study design. Before the study begins:
- All nursing and study personnel participating in the study will undergo routine in-service notification/training about the study.
After the study is open:
- While a potential participant at CSC, Penrose Hospital, or St. Francis Medical Center, patients who are determined to be in an active episode of AF by 12 Lead EKG, will be informed about the research study by research personnel and if they are interested in participating, the research personnel will proceed with the informed consent. Alternatively, patients of CSC with a known history of AF will be sent information on the study. If they are interested and have had > 3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study (even when in normal rhythm) with the intention of having the subject already enrolled in the study before their next episode of AF.
- After receiving informed consent and confirming eligibility, patients will have vital signs performed according to standard of care and a history taken. The subject will then be asked to answer the Cambridge Cognition test while in AF. This can happen on the same date the informed consent is performed.
- If a patient decides to drop out of the study after signing the consent form routine clinical care will be followed.
- The Cambridge Cognition test will be performed again at any point after 5 days from the termination of the AF episode after a 12 lead EKG confirms that they are no longer in AF (including after spontaneous conversion, pharmacologic cardioversion, electrical cardioversion, ablation or Maze procedure).
- The results of each subject's cognitive testing while in an acute episode of AF (experimental) will be compared to the results of the same subject's results in normal rhythm (control).
- Should a patient's AF episode not resolve within 6 months' time of the documented AF episode on the EKG the patient will be screen-failed and exited from the study without having taken the follow-up cognition test. All data collected prior to the subject exit will be kept for data analysis.
Number of Subjects Previous similar studies suggest various findings for their effect size11. However, all the findings have been consistently supporting association between atrial fibrillation and cognitive impairment. Based upon a power of 80% and alpha of 0.05, most of the studies suggesting a need of over 250 subjects (98-472), therefore up to 600 subjects will be recruited in this study with a goal of obtaining data on at least 250 participants.
PROCEDURES TO MINIMIZE RISKS To minimize risks associated with breach of confidentiality all data will be entered into Centura work stations where clinicians enter patient data into the Electronic Medical Record (EMR), which is the patient's clinical record, that includes firewall and password protection. Data pertinent to this study will be transferred to a Centura Health password protected computer in a non-identifiable manner. All identifiable data will be kept in a key protected room only accessible by the research staff.
To minimize risks associated with psychological discomfort as a result of taking the Cambridge Cognition test or its results, breaks will be given where appropriate and the patient will be reminded frequently that they may stop the test at any time should they feel uncomfortable.
- Conditions
- Atrial Fibrillation, Cognitive Symptom, Executive Dysfunction, Cognitive Change, Cognitive Impairment, Cognitive Impairment, Mild
- Being tested
- Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm
- Keywords
- atrial fibrillation, cognitive symptoms, executive dysfunction, cognitive change, cognitive impairment, tablet-based cognitive evaluation, Cambridge Cognition, CANTAB, Afib
- Medical subject headings
- Atrial Fibrillation, Neurobehavioral Manifestations, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythmOther
Also called Direct current cardioversion, PVAI, Minimally Invasive Surgical Maze, Medications
Direct current cardioversion, PVAI-atrial fibrillation ablation, Minimally Invasive Surgical Maze procedure, Medications
| Study group | Role | What they receive |
|---|---|---|
| AF/NR | Single cohort with a known or new diagnosis of atrial fibrillation, and intention attain/maintain normal rhythm. Subjects with be their own controls: Tablet-based cognitive testing to be performed while in atrial fibrillation (AF), and while they are in normal rhythm (NR). Results of both sets of cognitive testing will be compared. Receives: Other: Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cognitive Score in Atrial Fibrillation compared to Normal Rhythm
Cognitive score determined by Cambridge Cognition tablet-based cognitive testing software (CANTAB), determining if there is a significant difference between subjects in atrial fibrillation as compared to when those same subjects are in normal rhythm.
Measured: While in atrial fibrillation with the intention of regaining normal rhythm either through spontaneous, pharmacologic, direct current cardioversion, atrial fibrillation catheter ablation (PVAI), or Maze procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start14 Aug 2019
- Primary completion25 Nov 2024
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Brunk, PA-C, MMS
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Cardiac Alliance
- Responsible party
- Sponsor-investigator, David Brunk, PA-C, MMS, CommonSpirit Health
- Investigators
- David R Brunk, PA-C, MMS, Principal investigator, Common Spirit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033510
- Sponsor's protocol ID
- 1416701
- Acronym
- AFCOG
- Status last verified
- Oct 2025
- First submitted
- 24 Jul 2019
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
What is Atrial Fibrillation? American Heart Association (2017). Retrieved from: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/What-is-Atrial-Fibrillation-AFib-or-AF_UCM_423748_Article.jsp#.WuoR0aQvyUk on May, 2018.
Bajpai, A.; Savelieva, I.; Camm, AJ. Epidemiology AND Economic Burden of Atrial Fibrillation. Touch Briefings US Cardiovascular Disease (2007).
Writing Group Members; January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2019 Aug;16(8):e66-e93. doi: 10.1016/j.hrthm.2019.01.024. Epub 2019 Jan 28. No abstract available.
PubMed 30703530Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
PubMed 16818816Alonso A, Arenas de Larriva AP. Atrial Fibrillation, Cognitive Decline And Dementia. Eur Cardiol. 2016 Summer;11(1):49-53. doi: 10.15420/ecr.2016:13:2.
PubMed 27547248Ott A, Breteler MM, de Bruyne MC, van Harskamp F, Grobbee DE, Hofman A. Atrial fibrillation and dementia in a population-based study. The Rotterdam Study. Stroke. 1997 Feb;28(2):316-21. doi: 10.1161/01.str.28.2.316.
PubMed 9040682Dublin S, Anderson ML, Haneuse SJ, Heckbert SR, Crane PK, Breitner JC, McCormick W, Bowen JD, Teri L, McCurry SM, Larson EB. Atrial fibrillation and risk of dementia: a prospective cohort study. J Am Geriatr Soc. 2011 Aug;59(8):1369-75. doi: 10.1111/j.1532-5415.2011.03508.x. Epub 2011 Aug 1.
PubMed 21806558Marzona I, O'Donnell M, Teo K, Gao P, Anderson C, Bosch J, Yusuf S. Increased risk of cognitive and functional decline in patients with atrial fibrillation: results of the ONTARGET and TRANSCEND studies. CMAJ. 2012 Apr 3;184(6):E329-36. doi: 10.1503/cmaj.111173. Epub 2012 Feb 27.
PubMed 22371515Chen LY, Agarwal SK, Norby FL, Gottesman RF, Loehr LR, Soliman EZ, Mosley TH, Folsom AR, Coresh J, Alonso A. Persistent but not Paroxysmal Atrial Fibrillation Is Independently Associated With Lower Cognitive Function: ARIC Study. J Am Coll Cardiol. 2016 Mar 22;67(11):1379-80. doi: 10.1016/j.jacc.2015.11.064. No abstract available.
PubMed 26988962Knecht S, Oelschlager C, Duning T, Lohmann H, Albers J, Stehling C, Heindel W, Breithardt G, Berger K, Ringelstein EB, Kirchhof P, Wersching H. Atrial fibrillation in stroke-free patients is associated with memory impairment and hippocampal atrophy. Eur Heart J. 2008 Sep;29(17):2125-32. doi: 10.1093/eurheartj/ehn341. Epub 2008 Jul 29.
PubMed 18667399Kalantarian S, Stern TA, Mansour M, Ruskin JN. Cognitive impairment associated with atrial fibrillation: a meta-analysis. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):338-46. doi: 10.7326/0003-4819-158-5-201303050-00007.
PubMed 23460057
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cognitive Changes During Atrial Fibrillation Episodes (AFCOG)
- ClinicalTrials.gov ID
- NCT04033510
- Acronym / sponsor ID
- AFCOG / 1416701
- Conditions
- Atrial Fibrillation, Cognitive Symptom, Executive Dysfunction, Cognitive Change, Cognitive Impairment, Cognitive Impairment, Mild
- Keywords
- atrial fibrillation, cognitive symptoms, executive dysfunction, cognitive change, cognitive impairment, tablet-based cognitive evaluation, Cambridge Cognition, CANTAB
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- David Brunk, PA-C, MMSUniversity, hospital or other
- Collaborators
- Colorado Cardiac Alliance
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Jul 2019 (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.
Objectives:
- First, to determine if patients with a history of AF have acute measurable changes in cognitive functioning while in an episode of AF.
- Second, to collect basic insight into what specific physiologic (blood pressure, pulse oximetry, heart rate, temperature) and pharmacologic (antiarrhythmic medications, rate control medications, anticoagulants, antiplatelet medications, etc.) factors minimize the neurological impact on patients while they are in AF.
It is hypothesized that when using a tablet-based cognitive testing software - Cambridge Cognition (specifically to assess executive function, learning and working memory: Rapid Visual Information Processing test, Spatial Working Memory/Spatial Span Task tests, One touch Stockings of Cambridge test, Cambridge Gambling Task, Multitasking Test/Intra-Extra Dimensional Set shift tests) - a significant difference will be noted between how the patients perform while in atrial fibrillation compared to the patients' performance while in normal sinus rhythm.
Detailed description
Inclusion Criteria
- Subjects who are patients at Colorado Springs Cardiology (CSC) or Penrose-St. Francis Health Services.
- Patients who are between 35-80 years of age.
- Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to sinus rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).
- Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.
Method of Recruitment
- Study participants will be recruited after it is determined that they are acutely in an episode of AF by a standard of care 12-lead EKG (or KardiaApp), during an outpatient clinical visit (established patient clinical visits, consultations, or new patient visits) at CSC, or when being consulted on or rounded on at Penrose Hospital or St. Francis Medical Center.
- A baseline 12 lead EKG (or KardiaApp) at recruitment will establish or confirm the presence of AF
- The research personnel will review the consent for the study with the patient while they are in the CSC office or the patient's room if they are recruited during their time admitted to Penrose-St. Francis Health Services. After the patient has signed the consent, patient eligibility will be confirmed and the study process will continue.
Patients may also be phone consented and complete the testing at home via web-based testing.
- Patients of CSC with a known history of AF with be contacted with information on the study. If the patient is interested and have had >3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study with the intention of having the subject already enrolled in the study before their next episode of AF.
Procedure:
The study involves an observational study design. Before the study begins:
- All nursing and study personnel participating in the study will undergo routine in-service notification/training about the study.
After the study is open:
- While a potential participant at CSC, Penrose Hospital, or St. Francis Medical Center, patients who are determined to be in an active episode of AF by 12 Lead EKG, will be informed about the research study by research personnel and if they are interested in participating, the research personnel will proceed with the informed consent. Alternatively, patients of CSC with a known history of AF will be sent information on the study. If they are interested and have had > 3 documented episodes of AF over the preceding 12 months they will be invited to pre-enroll in the study (even when in normal rhythm) with the intention of having the subject already enrolled in the study before their next episode of AF.
- After receiving informed consent and confirming eligibility, patients will have vital signs performed according to standard of care and a history taken. The subject will then be asked to answer the Cambridge Cognition test while in AF. This can happen on the same date the informed consent is performed.
- If a patient decides to drop out of the study after signing the consent form routine clinical care will be followed.
- The Cambridge Cognition test will be performed again at any point after 5 days from the termination of the AF episode after a 12 lead EKG confirms that they are no longer in AF (including after spontaneous conversion, pharmacologic cardioversion, electrical cardioversion, ablation or Maze procedure).
- The results of each subject's cognitive testing while in an acute episode of AF (experimental) will be compared to the results of the same subject's results in normal rhythm (control).
- Should a patient's AF episode not resolve within 6 months' time of the documented AF episode on the EKG the patient will be screen-failed and exited from the study without having taken the follow-up cognition test. All data collected prior to the subject exit will be kept for data analysis.
Number of Subjects Previous similar studies suggest various findings for their effect size11. However, all the findings have been consistently supporting association between atrial fibrillation and cognitive impairment. Based upon a power of 80% and alpha of 0.05, most of the studies suggesting a need of over 250 subjects (98-472), therefore up to 600 subjects will be recruited in this study with a goal of obtaining data on at least 250 participants.
PROCEDURES TO MINIMIZE RISKS To minimize risks associated with breach of confidentiality all data will be entered into Centura work stations where clinicians enter patient data into the Electronic Medical Record (EMR), which is the patient's clinical record, that includes firewall and password protection. Data pertinent to this study will be transferred to a Centura Health password protected computer in a non-identifiable manner. All identifiable data will be kept in a key protected room only accessible by the research staff.
To minimize risks associated with psychological discomfort as a result of taking the Cambridge Cognition test or its results, breaks will be given where appropriate and the patient will be reminded frequently that they may stop the test at any time should they feel uncomfortable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF/NR | – | Other: Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythmSingle cohort with a known or new diagnosis of atrial fibrillation, and intention attain/maintain normal rhythm. Subjects with be their own controls: Tablet-based cognitive testing to be performed while in atrial fibrillation (AF), and while they are in normal rhythm (NR). Results of both sets of cognitive testing will be compared. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of Colorado Springs Cardiology: A Centura Health Clinic (CSC) with a history of, or new diagnosis of, Atrial fibrillation with the intention of being converted back to normal rhythm.
Key inclusion criteria (3 listed)
- Subjects who are patients at CSC or Penrose-St. Francis Health Services.
- Subjects actively in an episode of paroxysmal, or persistent AF (who are expected to receive treatment and converted back to normal rhythm (through antiarrhythmic drug therapy, direct current cardioversion, ablation or Maze/Minimally invasive Maze procedure).
- Subjects with a history of AF who have had >3 documented episodes of AF over the preceding 12 months and meet all other inclusion/exclusion criteria can pre-enroll. The cognition tests will be administered during the patient's next captured AF episode.
Key exclusion criteria (6 listed)
- Patients who had coronary bypass surgery during their life time.
- Patients with a previously documented history of post-pump syndrome during their life time.
- Patients with presence of, or medical diagnosis of Transient Ischemic Attack (TIA) or Cerebral Vascular Accident (CVA).
- Patients with presence of, or medical diagnosis of cognitive impairment (dementia, multiple sclerosis, traumatic brain injury, etc.).
- Female patients who are pregnant or post-partum.
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 |
|---|---|---|
| Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythmAlso: Direct current cardioversion, PVAI, Minimally Invasive Surgical Maze, MedicationsDirect current cardioversion, PVAI-atrial fibrillation ablation, Minimally Invasive Surgical Maze procedure, Medications | Other | AF/NR |
Primary outcome
Difference in Cognitive Score in Atrial Fibrillation compared to Normal Rhythm
Time frame: While in atrial fibrillation with the intention of regaining normal rhythm either through spontaneous, pharmacologic, direct current cardioversion, atrial fibrillation catheter ablation (PVAI), or Maze procedure.
Cognitive score determined by Cambridge Cognition tablet-based cognitive testing software (CANTAB), determining if there is a significant difference between subjects in atrial fibrillation as compared to when those same subjects are in normal rhythm.
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 14 Oct 2025.
- BackgroundWhat is Atrial Fibrillation? American Heart Association (2017). Retrieved from: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/What-is-Atrial-Fibrillation-AFib-or-AF_UCM_423748_Article.jsp#.WuoR0aQvyUk on May, 2018.
- BackgroundBajpai, A.; Savelieva, I.; Camm, AJ. Epidemiology AND Economic Burden of Atrial Fibrillation. Touch Briefings US Cardiovascular Disease (2007).
- Background: PubMed 30703530Writing Group Members; January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2019 Aug;16(8):e66-e93. doi: 10.1016/j.hrthm.2019.01.024. Epub 2019 Jan 28. No abstract available.
- Background: PubMed 16818816Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
- Background: PubMed 27547248Alonso A, Arenas de Larriva AP. Atrial Fibrillation, Cognitive Decline And Dementia. Eur Cardiol. 2016 Summer;11(1):49-53. doi: 10.15420/ecr.2016:13:2.
- Background: PubMed 9040682Ott A, Breteler MM, de Bruyne MC, van Harskamp F, Grobbee DE, Hofman A. Atrial fibrillation and dementia in a population-based study. The Rotterdam Study. Stroke. 1997 Feb;28(2):316-21. doi: 10.1161/01.str.28.2.316.
- Background: PubMed 21806558Dublin S, Anderson ML, Haneuse SJ, Heckbert SR, Crane PK, Breitner JC, McCormick W, Bowen JD, Teri L, McCurry SM, Larson EB. Atrial fibrillation and risk of dementia: a prospective cohort study. J Am Geriatr Soc. 2011 Aug;59(8):1369-75. doi: 10.1111/j.1532-5415.2011.03508.x. Epub 2011 Aug 1.
- Background: PubMed 22371515Marzona I, O'Donnell M, Teo K, Gao P, Anderson C, Bosch J, Yusuf S. Increased risk of cognitive and functional decline in patients with atrial fibrillation: results of the ONTARGET and TRANSCEND studies. CMAJ. 2012 Apr 3;184(6):E329-36. doi: 10.1503/cmaj.111173. Epub 2012 Feb 27.
- Background: PubMed 26988962Chen LY, Agarwal SK, Norby FL, Gottesman RF, Loehr LR, Soliman EZ, Mosley TH, Folsom AR, Coresh J, Alonso A. Persistent but not Paroxysmal Atrial Fibrillation Is Independently Associated With Lower Cognitive Function: ARIC Study. J Am Coll Cardiol. 2016 Mar 22;67(11):1379-80. doi: 10.1016/j.jacc.2015.11.064. No abstract available.
- Background: PubMed 18667399Knecht S, Oelschlager C, Duning T, Lohmann H, Albers J, Stehling C, Heindel W, Breithardt G, Berger K, Ringelstein EB, Kirchhof P, Wersching H. Atrial fibrillation in stroke-free patients is associated with memory impairment and hippocampal atrophy. Eur Heart J. 2008 Sep;29(17):2125-32. doi: 10.1093/eurheartj/ehn341. Epub 2008 Jul 29.
- Background: PubMed 23460057Kalantarian S, Stern TA, Mansour M, Ruskin JN. Cognitive impairment associated with atrial fibrillation: a meta-analysis. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):338-46. doi: 10.7326/0003-4819-158-5-201303050-00007.
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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. This study is not recruiting at the moment.
David R Brunk, PA-C, MMS principal investigator
Common Spirit
1 site 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 and Cognitive Symptom, run by David Brunk, PA-C, MMS at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Cognitive Score in Atrial Fibrillation compared to Normal Rhythm (time frame: While in atrial fibrillation with the intention of regaining normal rhythm either through spontaneous, pharmacologic, direct current cardioversion, atrial fibrillation catheter ablation (PVAI), or Maze procedure.). 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 NCT04033510, which also lists 11 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 14 Oct 2025.