NCT06935591 Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
| NCT ID | NCT06935591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vektor Medical |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 423 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 423 participants in total. It began in 2025-06-27 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study. 2. 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. 3. 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). 4. Subject is ≥ 22 years of age at time of enrollment/consent. 5. Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator. 6. Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, Exclusion Criteria: 1. 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). 2. 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. 3. 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. 4. 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. 5. Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice. 6. Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.
Frequently Asked Questions
Who can join the NCT06935591 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06935591 currently recruiting?
Yes, NCT06935591 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vektor Medical to inquire about joining.
Where is the NCT06935591 trial being conducted?
This trial is being conducted at Jonesboro, United States, Clearwater, United States, Jacksonville, United States, Tampa, United States and 9 additional locations.
Who is sponsoring the NCT06935591 clinical trial?
NCT06935591 is sponsored by Vektor Medical. The trial plans to enroll 423 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.