Atrial ArrhythmiaNCT07904377
ACORYS AI4AF PILOT STUDY
An observational study of Atrial Arrhythmia, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a Pilot Observational Study designed to record atrial electrophysiological activity in patients with atrial arrhythmias using non-invasive mapping technology. The primary objective is to develop and evaluate the capacity of novel artificial intelligence models (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Arrhythmia
- What is being tested?
- Acorys Mapping System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with atrial arrhythmia and referred for catheter ablation procedure.
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of paroxysmal AF, persistent (including longstanding) AF or atrial flutter
- o Definition of persistent AF per the 2023 AHA/ACC/HRS Guidelines: AF that is continuous and sustains for >7 d and requires intervention. Of note, patients with persistent AF who, with therapy, become paroxysmal should still be defined as persistent.
- Clinical indication for catheter ablation per SOC.
- Demonstrated willingness and ability to adhere to the study protocol, including provision of written informed consent
Who cannot join
- Age <18 years old
- Pregnancy or lactation
- Contraindications for catheter ablation
- Prior surgical/Convergent Ablation
- 2 or more prior PVIs
- Typical atrial flutter as the only clinical arrhythmia (anticipated cavotricuspid isthmus ablation only)
- Contraindications to use of the ACORYS Mapping System, such as open wounds, skin conditions, or known material sensitivities, including sensitivities to acrylic adhesives or silver
- Participation in another clinical trial that would interfere with study outcome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Konstantinos Siontis contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Heart Rhythm Services Research Team, (507) 255-0774
Konstantinos Siontis, MD, (507) 255-1051, Siontis.Konstantinos@mayo.edu
About this study
Official title: Pilot Observational Study for the Development of an Artificial Intelligence-Driven Methodology to Identify Optimal Atrial Ablation Strategies Using Non-Invasive Electrocardiographic Imaging (ACORYS-AI4AF Pilot Study)
This is a Pilot Observational Study designed to record atrial electrophysiological activity in patients with atrial arrhythmias using non-invasive mapping technology. The primary objective is to develop and evaluate the capacity of novel artificial intelligence models (i.e. ACORYS-AI4AF model) to predict post-ablation outcomes based on the data obtained from non-invasive mapping.
- Conditions
- Atrial Arrhythmia
- Being tested
- Acorys Mapping System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acorys Mapping SystemDevice
Acorys Mapping System is a non-invasive cardiac mapping system to be used as part of the electrophysiology procedure
| Study group | Role | What they receive |
|---|---|---|
| PVI (Pulmonary veins isolation)-Only | Not described Receives: Device: Acorys Mapping System | |
| PVI (Pulmonary veins isolation) + | Not described Receives: Device: Acorys Mapping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of accurate post ablation outcome predictions Percentage of Accurate Post-Ablation Outcome Predictions
The ACORYS-AI4AF model will use non-invasive mapping data collected during standard clinical procedures to predict post-ablation outcomes. Accuracy will be reported as the percentage of predictions that correctly correspond with the observed post-ablation outcome.
Measured: 12 Months
Number of Patients to remain arrhythmia-free after pulmonary vein isolation (PVI) alone
Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured through any of the following per standard of care procedures: 12-lead ECG, ambulatory rhythm monitoring devices, Consumer-facing wearable ECG devices (e.g., AliveCor KardiaMobile 6L, Apple Watch, etc), and Cardiac implanted electronic devices (implanted loop recorders, pacemakers, defibrillators).
Measured: 12 Months
Number of Patients not remaining arrhythmia-free after pulmonary vein isolation (PVI) and requiring additional atrial substrate ablation.
Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured by the number of patients to undergo a second atrial substrate ablation post procedure.
Measured: 12 Months
Secondary outcomes (3)
Percentage of patients with identified critical atrial regions contributing to arrhythmia maintenance for whom post-ablation outcomes were accurately predicted
Percentage of patients with identified critical atrial regions contributing to arrhythmia maintenance whose observed post-ablation outcome matched the outcome predicted based on the identified regions. Prediction accuracy is calculated as the proportion of correct predictions among all evaluated patients.
Measured: 12 Months
Accuracy of Imageless Electrocardiographic Imaging (ECGI) in Identifying Arrhythmogenic Substrates
The accuracy of Imageless Electrocardiographic Imaging (ECGI) in identifying arrhythmogenic substrates will be assessed by comparison with conventional electroanatomical mapping. Accuracy will be reported as the percentage of ECGI findings that correspond with findings from conventional electroanatomical mapping.
Measured: 12 Months
Percentage of procedures with successful mapping completed
Percentage of procedures with successful mapping completed will be determined by the findings that correspond with findings from conventional electroanatomical mapping.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start28 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Corify Care
- Responsible party
- Principal investigator, Konstantinos Siontis, Mayo Clinic
- Investigators
- Konstantinos Siontis, M.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904377
- Sponsor's protocol ID
- 24-013867
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study for the Development of an Artificial Intelligence-Driven Methodology to Identify Optimal Atrial Ablation Strategies Using Non-Invasive Electrocardiographic Imaging (ACORYS-AI4AF Pilot Study)
- ClinicalTrials.gov ID
- NCT07904377
- Acronym / sponsor ID
- 24-013867
- Conditions
- Atrial Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Corify Care
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
This is a Pilot Observational Study designed to record atrial electrophysiological activity in patients with atrial arrhythmias using non-invasive mapping technology. The primary objective is to develop and evaluate the capacity of novel artificial intelligence models (i.e. ACORYS-AI4AF model) to predict post-ablation outcomes based on the data obtained from non-invasive mapping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI (Pulmonary veins isolation)-Only | – | Device: Acorys Mapping System |
| PVI (Pulmonary veins isolation) + | – | Device: Acorys Mapping System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with atrial arrhythmia and referred for catheter ablation procedure.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Diagnosis of paroxysmal AF, persistent (including longstanding) AF or atrial flutter
- o Definition of persistent AF per the 2023 AHA/ACC/HRS Guidelines: AF that is continuous and sustains for >7 d and requires intervention. Of note, patients with persistent AF who, with therapy, become paroxysmal should still be defined as persistent.
- Clinical indication for catheter ablation per SOC.
- Demonstrated willingness and ability to adhere to the study protocol, including provision of written informed consent
Key exclusion criteria (8 listed)
- Age <18 years old
- Pregnancy or lactation
- Contraindications for catheter ablation
- Prior surgical/Convergent Ablation
- 2 or more prior PVIs
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 |
|---|---|---|
| Acorys Mapping SystemAcorys Mapping System is a non-invasive cardiac mapping system to be used as part of the electrophysiology procedure | Device | PVI (Pulmonary veins isolation) +, PVI (Pulmonary veins isolation)-Only |
Primary outcome
Percentage of accurate post ablation outcome predictions Percentage of Accurate Post-Ablation Outcome Predictions
Time frame: 12 Months
The ACORYS-AI4AF model will use non-invasive mapping data collected during standard clinical procedures to predict post-ablation outcomes. Accuracy will be reported as the percentage of predictions that correctly correspond with the observed post-ablation outcome.
Number of Patients to remain arrhythmia-free after pulmonary vein isolation (PVI) alone
Time frame: 12 Months
Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured through any of the following per standard of care procedures: 12-lead ECG, ambulatory rhythm monitoring devices, Consumer-facing wearable ECG devices (e.g., AliveCor KardiaMobile 6L, Apple Watch, etc), and Cardiac implanted electronic devices (implanted loop recorders, pacemakers, defibrillators).
Number of Patients not remaining arrhythmia-free after pulmonary vein isolation (PVI) and requiring additional atrial substrate ablation.
Time frame: 12 Months
Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured by the number of patients to undergo a second atrial substrate ablation post procedure.
3 secondary outcomes
Percentage of patients with identified critical atrial regions contributing to arrhythmia maintenance for whom post-ablation outcomes were accurately predicted
Time frame: 12 Months
Accuracy of Imageless Electrocardiographic Imaging (ECGI) in Identifying Arrhythmogenic Substrates
Time frame: 12 Months
Percentage of procedures with successful mapping completed
Time frame: 12 Months
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Arrhythmia
RecruitingPhase 2
A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
RecruitingObservational study
Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Cardiac Arrhythmia
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
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.
Konstantinos Siontis contact
Konstantinos Siontis, M.D principal investigator
Mayo Clinic
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 Arrhythmia, run by Mayo Clinic 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 5 inclusion and 8 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 29 Oct 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 Brooke Stanga (507-422-6692, stanga.brooke@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accurate post ablation outcome predictions Percentage of Accurate Post-Ablation Outcome Predictions (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 29 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.