Optimising Pacing Therapy, Integrated Medical Therapy, and Catheter AbLation for Atrial Fibrillation in Heart Failure Trial

Обзор

Atrial Fibrillation (AF) and Heart Failure (HF) are colliding global cardiovascular epidemics, individually impairing quality of life and cardiac performance, as well as increasing the risk of hospitalisation and mortality. When AF and HF co-exist, disease progression accelerates and the adverse outcomes are magnified, leading to incrementally higher morbidity, mortality, and healthcare expenditure. The management of AF has been dichotomised into the restoration and maintenance of sinus rhythm ("Rhythm control") or acceptance of AF with control of the ventricular response ("Rate control"). Previous studies suggested that pharmacologic rhythm control and pharmacologic rate control confer similar survival and morbidity outcomes in patients with significant left ventricular dysfunction. Recognising the limitations of pharmacotherapy, more recent studies have examined the utility of catheter ablation procedures, either designed to restore and maintain sinus rhythm (e.g., catheter-based pulmonary vein isolation) or control the ventricular response (e.g., pacemaker implantation in combination with catheter ablation of the atrioventricular junction). Compared to pharmacotherapy, these studies have suggested that catheter ablation may provide sustained improvements in quality of life, decreased hospitalisation and, potentially, improved survival for patients with co-existing AF and HF. However, these studies were performed prior to the modern era of quadruple LV enhancing therapy (beta-blocker, an angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and an SGLT2 inhibitor). The true impact of catheter-based interventions, and thus the optimal management of AF for patients with co-existing HF is not known. The investigators propose a randomised controlled trial to definitively answer the question regarding the optimal invasive treatment of AF in patients with heart failure with reduced ejection fraction (HFrEF - LVEF ≤ 40%).

Вмешательства

• Устройство Pulmonary Vein Isolation
  PVI
• Процедура Atrioventricular Node Ablation
  AVJ
• Препарат Pharmacological Rate Control
  Rate

Первичные конечные точки

• Composite of cardiovascular mortality, stroke, and total number of heart failure events [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Composite of ejection fraction, distance on the 6-minute walk test, and QOL score [Срок оценки: 1 year]
• Time to death from any cause [Срок оценки: 5 years]
• Time to death from cardiovascular cause [Срок оценки: 5 years]
• Number of Participants with unplanned emergency department visit or all-cause hospitalisation [Срок оценки: 5 years]
• Number of Participants with unplanned emergency department visit or hospitalisation for heart failure [Срок оценки: 5 years]
• Number of Participants with unplanned emergency department visit or hospitalisation for atrial fibrillation or arrhythmia [Срок оценки: 5 years]
• Number of Participants with heart failure event [Срок оценки: 5 years]
• Change in Quality of Life from baseline [Срок оценки: 5 years]
• Number of Participants with ischemic stroke or systemic arterial emboli [Срок оценки: 5 years]
• Number of Participants with new onset cognitive dysfunction [Срок оценки: 5 years]
• Change in left ventricular function (ejection fraction) [Срок оценки: 5 years]
• Time to first appropriate and inappropriate ICD intervention (ATP or ICD shock) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age of 18 years or older on the date of Informed Consent,
• Atrial fibrillation,
• Left ventricular ejection fraction of 40% or less, measured within 6 months of enrollment,
• Receiving stable foundational HF quadruple therapy at maximally tolerated dose,
• BNP ≥ 100 pg/mL (NT-proBNP ≥ 400 pg/ml), measured within 1 month of randomisation.

Критерии исключения

• Anticipated life expectancy less than one year from the consent date,
• Continuous atrial fibrillation of >1 year in duration,
• Left atrial anteroposterior diameter > 6 cm, volume > 100 mL, or volume index > 60 mL/m2,
• Previous left atrial ablation or left atrial surgery,
• The presence of a percutaneous left atrial appendage closure device,
• Uncontrolled hypo- or hyperthyroidism,
• Subject known to be pregnant or breast-feeding,
• Contraindication to oral anticoagulation therapy,
• Left atrial myxoma,
• Myocardial infarction or percutaneous coronary intervention within 3-months of consent,
• History of, or anticipated to undergo heart transplant, ventricular assist device insertion, or mitral or tricuspid valve repair or replacement within 3-months of the consent date.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07238452 · H24-02147

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗