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NCT Number: NCT07146061

pCAD-POAF 3 Year Follow-up

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, CAMS & PUMC

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No other intervention

Other

This is a observational study.

Primary outcomes

  1. AF burden

    Time frame: 3 year after the surgery

    the AF burden during 3-day continuous ECG monitoring among 2 groups at the 3 year follow-up.

Secondary outcomes

  1. Freedom of AF without the use of antiarrhymic medications or interventions

    Time frame: within 3 year after surgery

    Freedom of AF without the use of antiarrhymic medications or interventions

  2. The occurence of MACCE

    Time frame: within 3 year after surgery

    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

    Time frame: 3 year after the surgery

    AF incidence in 3 years and recorded by continuous ECG monitoring

  4. Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF

    Time frame: within 3 year after surgery

    Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF

  5. The mean, maximum, and minimum heart rate and HRV

    Time frame: 3 year after the surgery

    recorded by Holter monitoring at the 3 year follow-up visit

  6. Assessment of quality of life

    Time frame: 3 year after the surgery

    Assessed by EQ-5D-5L (EuroQol 5-Dimensions 5-Levels questionnaire, higher score means better outcome) and AFEQT (Atrial-Fibrillation-Effect-on-Quality-of-life-Questionnaire, higher score means better outcome).

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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