FARAPULSE™ Pulsed Field Ablation System

Официальное название

Real World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System

Обзор

To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.

Подробное описание

The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.

All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years.

Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).

Вмешательства

• Устройство FARAPULSE™ Pulsed Field Ablation system
  no intervention design in the study

Первичные конечные точки

• Failure-free rate [Срок оценки: 12 Months]
• Device-or procedure-related SAEs: [Срок оценки: 7 days and 12 months]
• Procedure- and device related adverse events [Срок оценки: 12 Months and 2 years and 3 years]

Критерии участия

Критерии включения

• Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
• Subjects whose age is 18 years or above.

Критерии исключения

• Subjects with a current interatrial baffle or patch
• Subjects with a known or suspected atrial myxoma
• Subjects with a myocardial infarction within 14 days prior to enrollment
• Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
• Subjects who do not tolerate anticoagulation therapy
• Subjects with an active systemic infection \*
• Subjects with a presence of atrial known thrombus \*
• Subjects with a known inability to obtain vascular access
• Subjects who are pregnant or planning to be pregnant
• Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
• Subjects with a life expectancy of ≤ 1 year per investigator's opinion
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.

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

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06762717 · PF333

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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