pCAD-POAF 3 Year Follow-up

NCT ID: NCT07146061

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Intervention Type OTHER

This is a observational study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no other intervention

This is a observational study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fuwai Hospital, CAMS & PUMC

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-GSP-GG-12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Optimal Ablation Strategies for Persistent AF With HF
NCT07153718 ACTIVE_NOT_RECRUITING NA
Cardiac Denervation in Aortic Arch Replacement
NCT06927908 NOT_YET_RECRUITING NA