Coronary Artery DiseaseNCT07146061
pCAD-POAF 3 Year Follow-up
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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 time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation
- What is being tested?
- no other intervention
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population enrolled previously in pCAD-POAF trial.
Who may be able to join
- This study will include the subjects who enrolled in pCAD-POAF trial
Who cannot join
- This study will include the subjects who enrolled in pCAD-POAF trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing
Wei Feng, MD, 010-88322265, fengwei@fuwai.com
Ziang Yang, MD, 010-88322265, yzang47@163.com
About this study
Official title: Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial
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 time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
The secondary outcomes are：the individual components of the primary composite outcome; unplanned all-cause rehospitalization; arrhythmias other than atrial fibrillation; premature atrial contraction and premature ventricular contraction burdens; heart rate variability parameters; quality-of-life scores; and other Holter-derived parameters.
Read the 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
- Being tested
- no other intervention
- Keywords
- coronary artery disease, atrial fibrillation
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no other interventionOther
This is a observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: no other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation.
The primary outcome was the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
Measured: 3 year after the surgery
Secondary outcomes (6)
the individual components of the primary composite outcome
the individual components of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation
Measured: within 3 year after surgery
unplanned all-cause rehospitalization
unplanned all-cause rehospitalization
Measured: within 3 year after surgery
premature atrial contraction and premature ventricular contraction burdens
premature atrial contraction and premature ventricular contraction burdens recorded by the 3-day continuous ECG monitoring
Measured: 3 year after surgery
Holter-derived parameter, mean heart rate
mean heart rate derived from the 3-day ECG monitoring
Measured: 3 year after the surgery
Holter-derived parameter, HRV
HRV derived from the 3-day ECG monitoring
Measured: 3 year after the surgery
Assessment of quality of life
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).
Measured: 3 year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wei Feng, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146061
- Sponsor's protocol ID
- 2025-GSP-GG-12
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial
- ClinicalTrials.gov ID
- NCT07146061
- Acronym / sponsor ID
- 2025-GSP-GG-12
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Keywords
- coronary artery disease, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
The secondary outcomes are：the individual components of the primary composite outcome; unplanned all-cause rehospitalization; arrhythmias other than atrial fibrillation; premature atrial contraction and premature ventricular contraction burdens; heart rate variability parameters; quality-of-life scores; and other Holter-derived parameters.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: no other interventionThis 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. |
| Control group | – | Other: no other interventionThis group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population enrolled previously in pCAD-POAF trial.
Key inclusion criteria (1 listed)
- This study will include the subjects who enrolled in pCAD-POAF trial
Key exclusion criteria (1 listed)
- This study will include the subjects who enrolled in pCAD-POAF trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no other interventionThis is a observational study. | Other | Control group, Intervention group |
Primary outcome
A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation.
Time frame: 3 year after the surgery
The primary outcome was the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.
6 secondary outcomes
the individual components of the primary composite outcome
Time frame: within 3 year after surgery
unplanned all-cause rehospitalization
Time frame: within 3 year after surgery
premature atrial contraction and premature ventricular contraction burdens
Time frame: 3 year after surgery
Holter-derived parameter, mean heart rate
Time frame: 3 year after the surgery
Holter-derived parameter, HRV
Time frame: 3 year after the surgery
Assessment of quality of life
Time frame: 3 year after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Feng, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation. (time frame: 3 year after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.