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Идёт набор NCT06212791

EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

— Наблюдательное Paroxysmal 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: Self- Report Evaluation-Duke Activity Status Index, Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, Cardiopulmonary exercise test (CPET), Transthoracic echocardiogram.
Кому может быть актуально
Состояния в реестре: Paroxysmal 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

EXCLAMATORY: EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation TO Reduce Atrial Fibrillation Burden and Correlation With Exercise CapacitY Longitudinal Study

Обзор

Longitudinal, observational cohort study to evaluate changes in left atrial (LA) reservoir function during exercise and overall exertional capacity in patients following catheter ablation for paroxysmal atrial fibrillation (AF).

Подробное описание

EXCLAMATORY is a longitudinal observational cohort clinical research study to evaluate the effects of catheter ablation for paroxysmal atrial fibrillation on left atrial and left ventricular performance during exercise, as well as effects on overall exercise capacity

Вмешательства

  • Поведенческое Self- Report Evaluation-Duke Activity Status Index
    Complete the Self- Report Evaluation-Duke Activity Status Index
  • Поведенческое Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire
    Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire
  • Диагностический тест Cardiopulmonary exercise test (CPET)
    Cardiopulmonary exercise test (CPET)
  • Диагностический тест Transthoracic echocardiogram
    Transthoracic echocardiogram at rest and immediately following peak exercise during CPET
  • Диагностический тест Ambulatory cardiac rhythm assessment
    Ambulatory cardiac rhythm assessment
  • Диагностический тест Cardiovascular magnetic resonance (CMR)
    Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)

Первичные конечные точки

  • Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF. [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
Вторичные конечные точки (6)
  • Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF. [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
  • Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol reserve after catheter ablation in patients with paroxysmal AF [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
  • Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) . [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
  • Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2 [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
  • Correlation between baseline AF burden and LA function, LV Function and pVO2 [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]
  • Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2. [Срок оценки: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Diagnosis of paroxysmal AF
  • Left ventricular ejection fraction ≥50%
  • Scheduled for catheter ablation
  • Able to speak, hear, and read English
  • Willing and able to provide informed consent

Критерии исключения

  • Persistent or permanent AF
  • Prior ablation (catheter based or surgical) for AF
  • Significant sinus node dysfunction
  • Implanted pacemaker or defibrillator
  • Contraindication to or inability to complete cardiovascular magnetic resonance study
  • Contraindication to or inability to complete exercise testing
  • Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2
  • Severe left ventricular hypertrophy
  • Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
  • Hypertrophic cardiomyopathy
  • Cardiac amyloidosis
  • Constrictive pericarditis
  • Pulmonary arterial hypertension
  • Prior cardiac surgery
  • Active pregnancy

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 · 1 центр
  • Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06212791 · HM20027087 · K23HL166956

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗