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Набор по приглашению NCT06335082

A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

— 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: Pulsed Field Ablation.
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
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Официальное название

A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation

Обзор

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).

Подробное описание

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). All types of AF including paroxysmal, persistent and long standing persistent may be included.

The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.

Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.

The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.

The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.

Вмешательства

  • Устройство Pulsed Field Ablation
    Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)

Первичные конечные точки

  • Long term effectiveness [Срок оценки: 12 months]
  • Long-term safety [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Patients who, in the opinion of the Investigator, are candidates for ablation for AF
  • Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
  • De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
  • 18 years of age or older
  • Able and willing to participate in baseline and follow up evaluations for the full length of the registry

Критерии исключения

  • Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
  • Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock.
  • In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 35 центров
  • Arrhythmia Institute at Grandview — Birmingham
  • Arrhythmia Research Group — Jonesboro
  • Sutter Health - California Pacific Medical Center — San Francisco
  • Community Memorial Health Systems — Ventura
  • South Denver Cardiology Associates — Littleton
  • The Arrythmia Center of South Florida — Delray Beach
  • Ascension St. Vincent's — Jacksonville
  • HCA Florida Mercy Hospital — Miami
  • … и ещё 27 центров

Публикации

  • Al-Ahmad A, Osorio J, Day J, Wasserlauf J, Nair D, Eckart R, Campbell D, Dukes J, Cuoco F, Costello J, Zagrodzky J, Kessler D, Morales G, Rajendra A, Oza S, Barakat A, Magnano A, Amin A, Silverstein J, Thosani A, Bezenek SM, Zei P, Dai C, Natale A, Horton R; DISRUPT AF Investigators. Patient and Procedural Factors Associated With Same-Day Discharge Following Pulsed Field Ablation for Atrial Fibril PMID 41331670

Идентификаторы

NCT: NCT06335082 · DISRUPT-AF

Первоисточники (государственные реестры)

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