Atrial FibrillationNCT05366361
The Dynamics of Human Atrial Fibrillation
An observational study of Atrial Fibrillation and Arrhythmias, Cardiac, run by Stanford University at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 30 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include men and women of any ethnicity aged >21 years referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts >7 days). Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of >or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
Who may be able to join
- referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts >7 days)
- Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of >or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
Who cannot join
- active coronary ischemia or decompensated heart failure
- atrial or ventricular clot on trans-esophageal echocardiography
- pregnancy (to minimize fluoroscopic exposure)
- inability or unwillingness to provide informed consent
- rheumatic valve disease (results in a unique AF phenotype)
- thrombotic disease or venous filters
- prior chest surgery is a relative contraindication for Maze surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen Mills, BA contact
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Sanjiv Narayan, MD, (650) 724-1850, sanjiv1@stanford.edu
Kathleen Mills, BA, kmills2@stanford.edu
About this study
Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. In this project, the applicant will develop a novel framework to better understand human AF that builds on agreement between several concepts for the disease. The applicant will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
Read the detailed description
The specific aim of this clinical study is to identify patients who will or will not respond to PVI, PVI plus other ablation or Maze surgery based on locations of organized-to-disorganized areas and clinical profile. We will develop non-invasive ECGI and intracardiac recordings in our registry, then test them prospectively in an observational study.
Premise: Identifying responders or non-responders to PVI alone, or PVI plus other ablation or Maze surgery may enable patient-tailored therapy. This may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). This proposal will prospectively test in single-arm observations studies if patients who exhibit large organized AF areas at planned ablation regions have higher procedural success than patients with smaller areas. We will use non-invasive ECGI indices of organized AF, based on Preliminary data(9, 84, 85).
This project is significant because it will establish a deeper understanding of AF and will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- ablation, arrhythmias, cardiac, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Clinically-Indicated Maze Surgery | This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery. | |
| Patients Undergoing Clinically-Indicated Ablation | This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the Area of Organized Regions in AF predict success from Ablation?
We will map areas of organized activity in all patients. We will compare if patients with success from ablation (absence of recurrent AF or atrial tachycardia on outpatient monitoring) have larger organized areas than those without success.
Measured: 1 year.
Secondary outcomes (1)
Does ablation through larger organized areas explain success from ablation.
We will map areas of organized activity in all patients. We will compare if patients with ablation lesions through organized areas, or that eliminates organized areas, have higher or lower success from ablation (determined by absence of recurrent AF or atrial tachycardia on outpatient monitoring) than patients in whom ablation did not encroach on organized areas.
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 posted9 May 2022
- Study start18 Aug 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anson M Lee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366361
- Sponsor's protocol ID
- 57424
- Status last verified
- Feb 2026
- First submitted
- 22 Apr 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamics of Human Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05366361
- Acronym / sponsor ID
- 57424
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- ablation, arrhythmias, cardiac, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 May 2022 (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.
Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. In this project, the applicant will develop a novel framework to better understand human AF that builds on agreement between several concepts for the disease. The applicant will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
Detailed description
The specific aim of this clinical study is to identify patients who will or will not respond to PVI, PVI plus other ablation or Maze surgery based on locations of organized-to-disorganized areas and clinical profile. We will develop non-invasive ECGI and intracardiac recordings in our registry, then test them prospectively in an observational study.
Premise: Identifying responders or non-responders to PVI alone, or PVI plus other ablation or Maze surgery may enable patient-tailored therapy. This may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). This proposal will prospectively test in single-arm observations studies if patients who exhibit large organized AF areas at planned ablation regions have higher procedural success than patients with smaller areas. We will use non-invasive ECGI indices of organized AF, based on Preliminary data(9, 84, 85).
This project is significant because it will establish a deeper understanding of AF and will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Clinically-Indicated Maze Surgery | – | –This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery. |
| Patients Undergoing Clinically-Indicated Ablation | – | –This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include men and women of any ethnicity aged >21 years referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts >7 days). Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of >or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
Key inclusion criteria (2 listed)
- referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts >7 days)
- Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of >or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
Key exclusion criteria (7 listed)
- active coronary ischemia or decompensated heart failure
- atrial or ventricular clot on trans-esophageal echocardiography
- pregnancy (to minimize fluoroscopic exposure)
- inability or unwillingness to provide informed consent
- rheumatic valve disease (results in a unique AF phenotype)
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
Does the Area of Organized Regions in AF predict success from Ablation?
Time frame: 1 year.
We will map areas of organized activity in all patients. We will compare if patients with success from ablation (absence of recurrent AF or atrial tachycardia on outpatient monitoring) have larger organized areas than those without success.
1 secondary outcome
Does ablation through larger organized areas explain success from ablation.
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 17 Feb 2026.
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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.
Kathleen Mills, BA contact
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 Arrhythmias, Cardiac, run by Stanford University 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 2 inclusion and 7 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 17 Feb 2026. 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?
Contact Anson Lee, MD ((650) 724-7500, ansonlee@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does the Area of Organized Regions in AF predict success from Ablation? (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.