Идёт набор NCT06935591

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

Без фазы С лечением Atrial Fibrillation (AF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Pulmonary Vein Isolation, vMap® + Pulmonary Vein Isolation.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation (AF). Базовые параметры: от 22 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation \[vMap®+PVI\]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.

Вмешательства

Процедура Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.
Устройство vMap® + Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.

Первичные конечные точки

Freedom from AF [Срок оценки: 12 months post procedure]

Вторичные конечные точки (6)

Freedom from AF and AT [Срок оценки: 12 months post procedure]
Total Procedure Time [Срок оценки: Interventional Procedure]
Total vMap® Mapping Time [Срок оценки: Interventional Procedure]
AF Burden [Срок оценки: 12 months post procedure]
Spontaneous AF Termination [Срок оценки: Interventional Procedure]
Total Fluoroscopy Dose [Срок оценки: Interventional Procedure]

Критерии участия

Критерии включения

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,

Критерии исключения

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).
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 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.
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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет