Incidence of Long-TeRm Atrial Fibrillation After Acute Illness

Официальное название

Incidence of Long-TeRm Atrial Fibrillation After Acute Illness (ILR-AF)

Обзор

The investigators seek to conduct a prospective study to assess the recurrence of AF in patients with acute AF using a long-term ECG monitoring strategy with an insertable cardiac monitor (ICM), which is clinically indicated in this scenario as part of the standard of care. The investigators hypothesize that patients diagnosed with acute AF in the setting of cardiac surgery will have higher rates of AF recurrence than acute AF diagnosed in the setting of non-cardiac surgery or medical illness.

Первичные конечные точки

• Time to first documented event of AF by 12 months [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Time to first documented AF by 6 months [Срок оценки: 6 months]
• Time to first documented AF episode lasting ≥ 5 minutes [Срок оценки: 12 months]
• Mean AF burden [Срок оценки: 12 months]
• Mean AF episode length [Срок оценки: 12 months]
• Change in use of oral anticoagulation and antiarrhythmic drugs [Срок оценки: 12 months]
• Quality of life scores (SF-36) [Срок оценки: 12 months]
• Incidence of hospitalization [Срок оценки: 12 months]
• Change in medication use [Срок оценки: 12 months]
• Incidence of stroke [Срок оценки: 12 months]
• Incidence of death [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patient has an existing clinical indication for implantation of an insertable cardiac monitor (ICM) and will undergo ICM implantation as part of their standard medical care.
• Patient is scheduled to receive or has received a Boston Scientific LUX-DX™ insertable cardiac monitor.
• Episode of acute AF. Acute AF is defined as AF detected in an acute care setting or during an acute illness. Before enrollment, the following tests are minimally required as standard tests to establish the diagnosis of acute AF:

• 12-lead ECG for AF detection
• 24-h ECG or telemetry monitoring for AF detection and PAC analysis
• Patient or legally authorized representative signs and dates the patient consent form.
• Patient is ≥18 years old.
• Patient is willing and able to comply with all study procedures and attend the required follow-up visits for the duration of the study.

Критерии исключения

• Patient has a known history of AF or atrial flutter prior to the index acute AF episode.
• Patient has another indication for antiarrhythmic medications according to AHA/ACC/HRS guidelines, independent of the acute AF episode.
• Patient has a permanent contraindication to oral anticoagulation (OAC) that, in the opinion of the treating physician, would preclude any future consideration of OAC for AF management.
• Patient is currently enrolled in another clinical trial that will affect the objectives or endpoints of this study.
• Patient's life expectancy is less than one year, as determined by the treating physician.
• Patient is pregnant.
• Patient has a current indication for implant with a cardiac implantable electronic device (CIED) such as a pacemaker or defibrillator, or an implantable hemodynamic monitoring system, as the study intervention would be redundant or potentially interfere with the clinical indication.
• Patient is not fit, able, or willing to follow the required procedures of the Clinical Investigation Plan.

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

• Sulpizio Cardiovascular Center — La Jolla

Идентификаторы

NCT: NCT07434674 · 812338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗