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Идёт набор NCT06436924

Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

— Наблюдательное 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: Left Atrial Appendage Device Implant.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation. Базовые параметры: от 18 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
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

Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Обзор

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.

Подробное описание

Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option.

Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. While there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the PINNACLE FLX clinical trial and the SURPASS analysis to ensure that safety and efficacy outcomes are comparable.

Additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of Watchman FLX™ implants in a single day. In the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.

Вмешательства

  • Устройство Left Atrial Appendage Device Implant
    The Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.

Первичные конечные точки

  • Peri-procedural complications [Срок оценки: Procedure through discharge, an average of 1-3 days]
  • Peri-device leakage [Срок оценки: Date of implant up to 90 days]
  • Late onset complications [Срок оценки: Discharge to 30 days.]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Able and willing to participate in baseline and follow up evaluations for the full length of the study
  • Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
  • Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
  • Having their LAAO device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

\*high-volume - a calendar day in which the single implanting physician schedules ≥ 8 LAAO device implant procedures, regardless of the device manufacturer

  • Willing and able to provide informed consent

Критерии исключения

  • Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  • In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
  • Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled < 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 7 центров
  • Grandview Medical Center — Birmingham
  • Pima Heart and Vascular — Tucson
  • The Medical Center of Aurora — Aurora
  • Ascension St. Vincent — Jacksonville
  • Naples Community Hospital — Naples
  • Memorial Health University Medical Center — Savannah
  • Medical University of South Carolina — Columbia

Идентификаторы

NCT: NCT06436924 · SAFE HV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗