pCAD-POAF 3 Year Follow-up

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Atrial Fibrillation

Treatments: Other: no other intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07146061

2025-GSP-GG-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

430 participants in 2 patient groups

Intervention group

Description:

This group underwent partial cardiac denervation procedure as well as CABG in the pCAD-POAF trial. However, no other intervention was performed after completing the pCAD-POAF trial.

Treatment:

Other: no other intervention

Control group

Description:

This group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial

Treatment:

Other: no other intervention