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Набор по приглашению NCT06747013

Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA

Без фазы С лечением Focal Ventricular Arrhythmias Premature Ventricular Contractions Ventricular Tachycardias

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: Point Ablation Catheter.
Кому может быть актуально
Состояния в реестре: Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias. 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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Обзор

The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.

Подробное описание

Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.

Sample Size - A total of 60 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.

Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.

Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.

Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.

Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (\>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.

Вмешательства

  • Устройство Point Ablation Catheter
    a point ablation catheter using a pulse field energy

Первичные конечные точки

  • Freedom from PVC/VT recurrence [Срок оценки: at 3 months following ablation procedure]
Вторичные конечные точки (3)
  • Incidence of Adverse events [Срок оценки: at 3 months following ablation procedure]
  • Incidence of Serious Adverse Events (SAEs) [Срок оценки: at 3 months following ablation procedure]
  • Incidence of non-serious adverse events [Срок оценки: at 3 months following ablation procedure]

Критерии участия

Критерии включения

Subjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:

  • Patient is planned for a catheter ablation procedure to ablate either:
  • Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS/EHRA/APHRS/LAHRS guidelines
  • Symptomatic Sustained Monomorphic Ventricular Tachycardia
  • Able and willing to provide written consent and comply with all testing and follow-up requirements
  • Above 18 years of age

Критерии исключения

  • Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)
  • Contraindication to anticoagulation
  • Life expectancy or other disease processes likely to limit survival to less than 12 months.
  • Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
  • NYHA Class IV heart failure
  • Severe, untreated coronary artery disease which would preclude infusion of provocative agents
  • Severe aortic stenosis (AVA < 1.0cm, or PG > 64mmHg)
  • Severe mitral regurgitation.
  • Allergy to contrast which is unable to be adequately pre-medicated.
  • Acute non-cardiovascular illness or systemic infection
  • Thrombocytopenia (platelet count < 50,000/mm3) or coagulopathy unless corrected
  • Cardiogenic shock unrelated to ventricular arrhythmias
  • Pregnancy or anticipated pregnancy during study follow-up
  • PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT06747013 · STUDY-24-00971

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗