Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07904377

Conditions

Atrial Arrhythmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acorys Mapping System

Study Details

Brief 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. ACORYS-AI4AF model) to predict post-ablation outcomes based on the data obtained from non-invasive mapping.

Conditions

Atrial Arrhythmia

Study ID

NCT07904377

Start date

Jan 28, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

PVI (Pulmonary veins isolation)-Only

PVI (Pulmonary veins isolation) +

Interventions

Acorys Mapping System

Acorys Mapping System is a non-invasive cardiac mapping system to be used as part of the electrophysiology procedure

Primary outcome measure

  • Percentage of accurate post ablation outcome predictions Percentage of Accurate Post-Ablation Outcome Predictions [ Time Frame: 12 Months ]
  • Number of Patients to remain arrhythmia-free after pulmonary vein isolation (PVI) alone [ Time Frame: 12 Months ]
  • Number of Patients not remaining arrhythmia-free after pulmonary vein isolation (PVI) and requiring additional atrial substrate ablation. [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Brooke Stanga

507-422-6692stanga.brooke@mayo.edu

Konstantinos Siontis

Siontis.Konstantinos@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Heart Rhythm Services Research Team

(507) 255-0774

Konstantinos Siontis, MD

(507) 255-1051Siontis.Konstantinos@mayo.edu

Principal Investigator:

Konstantinos Siontis, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.