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New treatment option for Atrial Fibrillation (AF)
Official title Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
ClinicalTrials.gov ID: NCT06935591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- people 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...
- The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be...
- Atrial fibrillation type
- Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency...
You likely can't join if
- people with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation...
- 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...
- people who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned...
- people who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in...
- people 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.
See the full eligibility criteria
- people 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)...
- 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...
- 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,
- people 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).
- 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.
- people 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.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Clearwater, Florida, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Valhalla, New York, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Munich, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Clearwater, Florida, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Athens, Georgia, United States; Atlanta, Georgia, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.