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Набор по приглашению NCT06988202

Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

Без фазы С лечением Atrial Fibrillation (AF)

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: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI).
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation (AF). 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

Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation

Обзор

Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.

Вмешательства

  • Процедура Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)
    A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart. Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart. These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm.
  • Процедура Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
    PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.

Первичные конечные точки

  • Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS) [Срок оценки: From Baseline to Month 12]
Вторичные конечные точки (4)
  • Time to First Atrial Fibrillation Episode Lasting > 30 Seconds [Срок оценки: Up to 24 Months Following Randomization]
  • Mean Total Atrial Fibrillation Burden from Serial Holter Recordings [Срок оценки: From Randomization through Month 24]
  • Mean Total Number of Cardiovascular Health Care Utilization Events [Срок оценки: From Randomization through Month 48]
  • Mean Total Number of Major Clinical Events [Срок оценки: From Randomization through Month 48]

Критерии участия

Критерии включения

  • Age ≥ 18 years on date of consent
  • One prior PVI ablation procedure > 3 months prior for persistent AF
  • Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
  • Eligible for repeat ablation procedure
  • Willingness to comply with all post-procedural follow-up requirements and to sign informed consent

Критерии исключения

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
  • Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
  • Prior surgical ablation for AF
  • Contraindication to systematic anticoagulation
  • LA diameter on echocardiogram > 6.0 cms
  • LV ejection fraction < 35%
  • NYHA class III-IV congestive heart failure
  • Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
  • Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
  • Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
  • Prior valve replacement with mechanical prosthesis
  • Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
  • Stroke within 3 calendar months prior to consent date
  • Any medical condition likely to limit survival to < 1 year
  • Renal failure requiring dialysis at time of consent
  • Pregnancy
  • History of non-compliance to medical therapy
  • Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
  • Inability or unwillingness to provide informed consent
  • Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
  • Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Rochester Clinical Cardiovascular Research Center — Rochester

Идентификаторы

NCT: NCT06988202 · STUDY00010537

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗