Cardiac DenervationNCT05009914
A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.
A study testing cardiac denervation in people with Cardiac Denervation and Postoperative Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Denervation, Postoperative Atrial Fibrillation
- What is being tested?
- cardiac denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing simple CABG (on-pump/off-pump) for the first time.
- Patients who signed the informed consent form and willing to undergo cardiac denervation.
Who cannot join
- Age < 18；
- Emergent CABG;
- Cardiac surgery history；
- Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
- Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
- History of AF ;
- Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.
This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.
- Being tested
- cardiac denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac denervationProcedure or surgery
Excision of Marshall ligament and Waterstone fat pad during CABG.
| Study group | Role | What they receive |
|---|---|---|
| cardiac denervation group | Experimental | In this group, patients undergoing CABG will receive the procedure of our new way of cardiac denervation, excision of Marshall ligament and Waterstone fat pad. Receives: Procedure: cardiac denervation |
| controlled group | No intervention | In this group ,patients undergoing CABG will not receive the procedure of cardiac denervation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POAF during hospital.
Incidence of postoperative atrial fibrillation after surgery during hospital.
Measured: 6 days after surgery.
Secondary outcomes (8)
Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.
The incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation during in-hospital time.
Measured: Postoperative hospitalization, an average of 8 days.
Incidence of transferring to on-pump CABG caused by cardiac denervation.
The incidence of transferring to on-pump CABG caused by cardiac denervation during in-hospital time.
Measured: Intraoperatively.
Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.
The incidence of re-operation aiming to stop bleeding caused by cardiac denervation during in-hospital time.
Measured: Postoperative hospitalization, an average of 8 days.
Incidence of pericarial effusion within 30 days after discharged.
The incidence of pericarial effusion within 30 days after discharged.
Measured: within 30 days after discharged.
Incidence of arrhythmia exclude of AF within 30 days after discharged.
The incidence of arrhythmia exclude of AF within 30 days after discharged.
Measured: within 30 days after discharged.
Postoperative length of hospitalization.
Each participant's oostoperative length of hospitalization.
Measured: Postoperative hospitalization, an average of 8 days.
All cost after surgery.
All cost associated with treatment after surgery during in-hospital time.
Measured: Postoperative hospitalization, an average of 8 days.
MACCE
major adverse cardiovascular and cerebrovascular events (MACCE), which was defined as the composite of stroke, myocardial infarction, repeat coronary revascularization and all-cause mortality during the 30-day follow-up.
Measured: within 30 days after discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Aug 2022
- Primary completion13 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DenervationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wei Feng, MD PhD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009914
- Sponsor's protocol ID
- NCRC2020003
- Status last verified
- May 2024
- First submitted
- 29 Jun 2021
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Z, Tiemuerniyazi X, Xu F, Wang Y, Sun Y, Yan P, Tian L, Han C, Zhang Y, Pan S, Hu Z, Li X, Zhao W, Feng W. Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):71-77. doi: 10.1001/jamacardio.2024.4639.
PubMed 39550720
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT05009914
- Acronym / sponsor ID
- NCRC2020003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 18 Aug 2021 (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 is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac denervation group | Experimental | Procedure: cardiac denervationIn this group, patients undergoing CABG will receive the procedure of our new way of cardiac denervation, excision of Marshall ligament and Waterstone fat pad. |
| controlled group | No intervention | –In this group ,patients undergoing CABG will not receive the procedure of cardiac denervation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing simple CABG (on-pump/off-pump) for the first time.
- Patients who signed the informed consent form and willing to undergo cardiac denervation.
Key exclusion criteria (7 listed)
- Age < 18；
- Emergent CABG;
- Cardiac surgery history；
- Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
- Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
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 |
|---|---|---|
| cardiac denervationExcision of Marshall ligament and Waterstone fat pad during CABG. | Procedure or surgery | cardiac denervation group |
Primary outcome
Incidence of POAF during hospital.
Time frame: 6 days after surgery.
Incidence of postoperative atrial fibrillation after surgery during hospital.
8 secondary outcomes
Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.
Time frame: Postoperative hospitalization, an average of 8 days.
Incidence of transferring to on-pump CABG caused by cardiac denervation.
Time frame: Intraoperatively.
Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.
Time frame: Postoperative hospitalization, an average of 8 days.
Incidence of pericarial effusion within 30 days after discharged.
Time frame: within 30 days after discharged.
Incidence of arrhythmia exclude of AF within 30 days after discharged.
Time frame: within 30 days after discharged.
Postoperative length of hospitalization.
Time frame: Postoperative hospitalization, an average of 8 days.
All cost after surgery.
Time frame: Postoperative hospitalization, an average of 8 days.
MACCE
Time frame: within 30 days after discharged.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 39550720Yang Z, Tiemuerniyazi X, Xu F, Wang Y, Sun Y, Yan P, Tian L, Han C, Zhang Y, Pan S, Hu Z, Li X, Zhao W, Feng W. Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):71-77. doi: 10.1001/jamacardio.2024.4639.
- Individual participant dataSharing planned: No
Related trials for Cardiac Denervation
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
Recruiting
Renal Denervation + PVI vs PVI Alone for Persistent AF
Atrial Fibrillation
RecruitingObservational study
pCAD-POAF 3 Year Follow-up
Coronary Artery Disease, Atrial Fibrillation
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. This study is not recruiting at the moment.
Wei Feng, MD PhD study chair
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?
A study testing cardiac denervation in people with Cardiac Denervation and Postoperative 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POAF during hospital. (time frame: 6 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009914, which also lists 1 linked publication.
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 13 May 2024.