NCT07146061

pCAD-POAF 3 Year Follow-up

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 430 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	no other intervention	This is a observational study.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: China