Идёт набор NCT06455098

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Без фазы С лечением Atrial Fibrillation

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: OMNYPULSE™ Catheter with the TRUPULSE Generator.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation. Базовые параметры: 18 лет — 80 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, Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

Обзор

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Вмешательства

Устройство OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

Первичные конечные точки

Number of Participants with Primary Adverse Events (PAEs) [Срок оценки: 7 days post-procedure]
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes [Срок оценки: Day 91 to Day 365 post-procedure]

Вторичные конечные точки (1)

Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [Срок оценки: Baseline, Month 12]

Критерии участия

Критерии включения

Diagnosed with symptomatic paroxysmal AF with:

At least two symptomatic AF episodes within last six months from enrollment
At least one electrocardiographically documented AF episode within twelve months prior to enrollment
Failed at least one Class I or Class III antiarrhythmic drug
Willing and capable to provide consent
Able and willing to comply with all pre-, post- and follow-up testing and requirements

Критерии исключения

Previously diagnosed with persistent AF (greater than \[>\] 7 days in duration)
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Previous surgical or catheter ablation for AF
Patients known to require ablation outside the PV ostia and outside the CTI region.
Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
Valvular cardiac surgical/percutaneous procedure
Unstable angina within 6 months
Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Prior diagnosis of pulmonary vein stenosis
Pre-existing hemi diaphragmatic paralysis
Acute illness, active systemic infection, or sepsis
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
Severe mitral regurgitation
Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
Presence of a condition that precludes vascular access
Current enrollment in an investigational study evaluating another device or drug
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
Life expectancy less than 12 months
Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)