Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
430 participants
OBSERVATIONAL
2025-08-31
2027-01-31
Brief Summary
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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 areļ¼1. 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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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention group
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.
no other intervention
This is a observational study.
Control group
This group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial
no other intervention
This is a observational study.
Interventions
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no other intervention
This is a observational study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Wei Feng, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital, CAMS & PUMC
Beijing, , China
Countries
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Other Identifiers
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2025-GSP-GG-12
Identifier Type: -
Identifier Source: org_study_id
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