pCAD-POAF 3 Year Follow-up

Официальное название

Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial

Обзор

This study will include the subjects who enrolled in pCAD-POAF trial (NCT05009914) to observe clinical outcomes 3 years after surgery. The primary outcome is the AF burden during 3-day continuous ECG monitoring among 2 groups in pCAD-POAF trial 3 years after surgery. The secondary outcomes are：1. Freedom of AF without the use of antiarrhymic medications or interventions ; 2. The occurence of MACCE (including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure); 3. AF incidence in 3 years and recorded by continuous ECG monitoring; 4. Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF; 5. The mean, maximum, and minimum heart rate recorded by Holter monitoring, as well as heart rate variability (HRV); 6. Quality of life assessment, such as EQ-5D-5L and AFEQT.

Подробное описание

This study aimed to observe clinical outcomes 3 years after surgery in patients enrolled in pCAD-POAF trial.

After completing the pCAD-POAF trial, investigators would not make any other interventions on enrolled patients. At the 3 year follow-up visit, all subjects will undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG). Besides, coronary computed tomographic angiography(CCTA) will be performed depending on their own willingness. In the meantime, all subjects will be continuously monitored by wearing specific device for the detection of arrhythmias. Data collection will also include the use of medications, medical tests, any documented arrhythmias and the occurrence of clinical events within the 3 years.

In conclusion, this is a extensive follow-up of previous RCT and a non-interventional, observational study.

Вмешательства

• Другое no other intervention
  This is a observational study.

Первичные конечные точки

• AF burden [Срок оценки: 3 year after the surgery]

Вторичные конечные точки (6)

• Freedom of AF without the use of antiarrhymic medications or interventions [Срок оценки: within 3 year after surgery]
• The occurence of MACCE [Срок оценки: within 3 year after surgery]
• AF incidence in 3 years and recorded by continuous ECG monitoring [Срок оценки: 3 year after the surgery]
• Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF [Срок оценки: within 3 year after surgery]
• The mean, maximum, and minimum heart rate and HRV [Срок оценки: 3 year after the surgery]
• Assessment of quality of life [Срок оценки: 3 year after the surgery]

Критерии участия

Критерии включения

• This study will include the subjects who enrolled in pCAD-POAF trial

Критерии исключения

• This study will include the subjects who enrolled in pCAD-POAF trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fuwai Hospital, CAMS & PUMC — Пекин

Идентификаторы

NCT: NCT07146061 · 2025-GSP-GG-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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