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Набор скоро начнётся NCT06817447

Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

Без фазы С лечением Atrial Flutter Typical Heart Failure

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 plus cavo-tricuspid isthmus ablation, Cavo-tricuspid isthmus ablation.
Кому может быть актуально
Состояния в реестре: Atrial Flutter Typical, Heart Failure. Базовые параметры: 18 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
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

Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study

Обзор

This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.

Вмешательства

  • Процедура Pulmonary vein isolation plus cavo-tricuspid isthmus ablation
    For those who are randomized to CTI+CPVI Arm, additional CPVI should be performed after finishing CTI ablation. CPVI could be performed using open-irrigated contact-force catheter, cryoballoon catheter or pulse-field ablation catheter. The endpoint is defined as both entrance and exit block in the pulmonary veins.
  • Процедура Cavo-tricuspid isthmus ablation
    In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. CTI ablation should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. Radiofrequency should be delivered at 30-50 W with a cont

Первичные конечные точки

  • Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
Вторичные конечные точки (11)
  • Time to cardiovascular death [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to hospitalization or urgent visits for heart failure [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to hospitalization for heart failure [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to urgent visits for heart failure [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to all-cause death [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to atrial fibrillation recurrence [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Time to change of diuretics [Срок оценки: From randomization until completion of the planned follow-up, assessed up to 48 months]
  • Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year [Срок оценки: One-year]
  • Change in 6-minute walk test at one-year [Срок оценки: One-year]
  • Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year [Срок оценки: One-year]
  • Change in New York Heart Association (NYHA) class at one-year [Срок оценки: One-year]

Критерии участия

Критерии включения

  • Aged 18 to 80 years
  • Typical AFL referring for ablation
  • No prior history of AF
  • Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) >125 pg/ml in sinus rhythm or >365 pg/ml in AFL
  • Optimized guideline-directed medical therapy for HF for at least one month
  • A minimum of anticoagulation for three weeks
  • Sign informed consent

Критерии исключения

  • Any AF episodes documented during 48-hour Holter monitoring
  • Presence of left atrial thrombus
  • HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
  • Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
  • Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
  • Untreated hypothyroidism or hyperthyroidism
  • Dialysis-dependent terminal renal failure
  • Life expectancy <12 months due to non-cardiovascular causes.
  • Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
  • Female under pregnancy or breast-feeding
  • Involved in other studies

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06817447 · 2025-SR-026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗