Tests an AI heart-mapping tool added to standard ablation for atrial fibrillation
Compares AI heart mapping plus pulmonary vein isolation with pulmonary vein isolation alone in adults.
Plain-language title generated from the registry record
Registry title: Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Key facts
- Where
- Munich, GermanySee the site
Where in Germany
- German Heart CenterMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vektor Medical
- Trial code
- NCT06935591
- Record updated
- 16 March 2026
- Original description
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults.Read full original descriptionShow less
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults.
Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).
Inclusion: Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study; Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format; The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):; Atrial fibrillation type; Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s); Subject is ≥ 22 years of age at time of enrollment/consent; Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator; Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,.
Exclusion: Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads; Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation; Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice; Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure; Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis); Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.