pCAD-POAF 3 Year Follow-up

NCT07146061 | Not Yet Recruiting

• 1 other identifier: 2025-GSP-GG-12
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Atrial Fibrillation

Keywords

coronary artery disease; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• AF burden

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

  3 year after the surgery

Secondary Outcomes (6)

• Freedom of AF without the use of antiarrhymic medications or interventions

  within 3 year after surgery

• The occurence of MACCE

  within 3 year after surgery

• AF incidence in 3 years and recorded by continuous ECG monitoring

  3 year after the surgery

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

  within 3 year after surgery

• The mean, maximum, and minimum heart rate and HRV

  3 year after the surgery

Study Arms (2)

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.

Other: no other intervention

Control group

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

Other: no other intervention

Interventions

no other intervention OTHER

This is a observational study.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population enrolled previously in pCAD-POAF trial.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, CAMS & PUMC

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Feng, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)