Postoperative Atrial FibrillationCALMNCT07918781
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
A study testing Partial Cardiac Denervation in people with Postoperative Atrial Fibrillation and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 5 sites in China.
Trial summary
Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery and is associated with increased risks of mortality, stroke, myocardial infarction, and hospital readmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- Partial Cardiac Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 5 sitesChina
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled to undergo isolated coronary artery bypass grafting, either with or without cardiopulmonary bypass.
- Able and willing to provide written informed consent.
- No atrial fibrillation detected on preoperative 24-hour electrocardiographic monitoring.
Who cannot join
- Previous cardiac surgery.
- Emergency surgery.
- Preoperative critical condition.
- Left ventricular ejection fraction of 30% or lower.
- Left atrial diameter greater than 50 mm.
- Prior history of atrial fibrillation.
- Use of antiarrhythmic medications other than beta-blockers within 2 weeks before surgery.
- Planned concomitant cardiac procedures, including but not limited to congenital heart disease surgery or left ventricular reconstruction.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Fuwai Hospital, PUMC & CAMS
Beijing, Beijing Municipality, 100000
Wei Feng, M.D., 86+13801018685, fengwei@fuwai.com
Wei Feng, M.D.
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Xiaobo Liao, M.D.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Qiang Gao, M.D.
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Fei Xiang, M.D.
Fuwai Central China Cardiovascular Hospital
Zhenzhou, Henan, 451464
Junlong Hu, M.D.
About this study
Official title: Cardiac Autonomic Neuromodulation in Myocardial Revascularization (CALM): A Multicenter Randomized Controlled Trial of Partial Cardiac Denervation for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting
Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery and is associated with increased risks of mortality, stroke, myocardial infarction, and hospital readmission. The cardiac autonomic nervous system plays an important role in the development of POAF and may represent a potential target for preventive intervention.
The CALM trial is a multicenter, randomized controlled trial designed to evaluate the efficacy and safety of partial cardiac denervation for the prevention of POAF in patients undergoing isolated coronary artery bypass grafting (CABG). A total of approximately 1,470 participants will be randomly assigned in a 1:1 ratio to undergo CABG with partial cardiac denervation or CABG alone. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.
The trial will evaluate the incidence of POAF within the first 6 postoperative days and the occurrence of long-term adverse clinical events. Participants will undergo scheduled rhythm monitoring and clinical follow-up, and all participants will be followed until the last enrolled participant completes 3 years of follow-up after surgery.
Read the detailed description
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass grafting (CABG) and is associated with increased risks of stroke, myocardial infarction, prolonged hospitalization, and other adverse outcomes. Autonomic imbalance and excessive activation of the intrinsic cardiac autonomic nervous system are considered important contributors to the development of POAF. Previous studies of pharmacological or biological autonomic modulation have shown variable efficacy, and their effects may be transient.
A previous single-center randomized trial conducted by the investigators showed that partial cardiac denervation, consisting of transection of the ligament of Marshall and resection of the Waterston fat pad, reduced the incidence of POAF after CABG without increasing perioperative complications. The CALM trial is designed to evaluate whether these findings can be reproduced across multiple centers and to investigate the potential long-term clinical and autonomic effects of this intervention.
This is a prospective, multicenter, randomized controlled trial involving approximately 1,470 patients undergoing isolated CABG with or without cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to partial cardiac denervation in addition to standard CABG or to standard CABG alone. Centralized randomization will be stratified by participating center and baseline CHA2DS2-VASc score. Treatment allocation will be disclosed to the operating surgeon only after induction of anesthesia. Participants, outcome assessors, electrocardiographic reviewers, clinical event adjudicators, and statisticians will remain blinded to treatment allocation.
In the intervention group, the ligament of Marshall, located between the left atrial appendage and the left pulmonary veins, will be transected using electrocautery. The Waterston fat pad, located in the interatrial groove between the right atrium and the right pulmonary veins, will then be completely resected down to the epicardial surface. No additional denervation procedure will be performed in the control group. Other aspects of CABG and perioperative care will follow routine clinical practice at each participating center.
Continuous electrocardiographic monitoring will be performed during the early postoperative period, and scheduled ambulatory electrocardiographic monitoring will be conducted during follow-up. Electrocardiographic recordings will be centrally reviewed by an independent ECG Core Laboratory. Suspected clinical endpoint events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Participants will undergo scheduled clinical follow-up for assessment of arrhythmias, cardiac autonomic function, and long-term clinical outcomes. All participants will be followed until the last enrolled participant has completed 3 years of follow-up after surgery.
- Being tested
- Partial Cardiac Denervation
- Keywords
- Postoperative Atrial Fibrillation, Coronary Artery Bypass Grafting, Partial Cardiac Denervation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Cardiac DenervationProcedure or surgery
The intervention has been described in previous studies. Briefly, intraoperative partial cardiac denervation is achieved by transection of the left LOM and resection of the right Waterston fat pad using electrocautery.
During the procedure, the pulmonary trunk is first gently retracted to the right to expose the LOM located between the left atrial appendage and the left pulmonary veins. The LOM is then transected using electrocautery. Subsequently, the right atrium is retracted to the left to expose the Waterston fat pad located in the interatrial groove. The Waterston fat pad is completely excised with electrocautery down to the epicardial surface.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | CABG alone |
| Intervention group | Experimental | Partial cardiac denervation + CABG. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad. Receives: Procedure: Partial Cardiac Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Atrial Fibrillation Within 6 Postoperative Days
The proportion of participants with documented new-onset postoperative atrial fibrillation (POAF). POAF is defined as an episode of atrial fibrillation characterized by irregularly irregular RR intervals and the absence of discernible P waves, lasting more than 30 seconds. Continuous electrocardiographic recordings will be centrally reviewed by the blinded ECG Core Laboratory.
Measured: From admission to the intensive care unit after surgery until postoperative day 6.
Time to First Occurrence of the Composite Clinical Outcome
Time from surgery to the first occurrence of any component of the composite outcome, including all-cause death, stroke, systemic embolism, myocardial infarction, readmission for cardiac reasons, or post-discharge atrial fibrillation. Suspected clinical events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Post-discharge atrial fibrillation events will be reviewed by the blinded ECG Core Laboratory.
Measured: From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.
Secondary outcomes (17)
Postoperative Length of Hospital Stay
The number of days from the date of surgery to hospital discharge.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Total Hospitalization Costs
Total medical costs incurred during the index hospitalization.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative All-Cause Mortality
The proportion of participants who die from any cause during the perioperative hospitalization.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative New-Onset Stroke
The proportion of participants who experience a new-onset stroke during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative Myocardial Infarction
The proportion of participants who experience myocardial infarction during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Postoperative Atrial Fibrillation Burden Within 6 Postoperative Days
The proportion of analyzable electrocardiographic monitoring time spent in atrial fibrillation during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
Measured: From admission to the intensive care unit after surgery until postoperative day 6.
Number of Postoperative Atrial Fibrillation Episodes Within 6 Postoperative Days
The total number of documented postoperative atrial fibrillation episodes per participant during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
Measured: From admission to the intensive care unit after surgery until postoperative day 6.
Duration of Postoperative Atrial Fibrillation Within 6 Postoperative Days
The cumulative duration of documented postoperative atrial fibrillation episodes during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
Measured: From admission to the intensive care unit after surgery until postoperative day 6.
Incidence of Post-Discharge Atrial Fibrillation
The proportion of participants with atrial fibrillation documented after discharge by scheduled 3-day ambulatory electrocardiographic monitoring or by clinically obtained electrocardiographic recordings. All suspected events will be reviewed by the blinded ECG Core Laboratory.
Measured: From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Post-Discharge Atrial Fibrillation Burden
The proportion of analyzable ambulatory electrocardiographic monitoring time spent in atrial fibrillation during each scheduled 3-day monitoring period, as determined by the blinded ECG Core Laboratory.
Measured: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Non-Atrial Fibrillation Arrhythmias
The proportion of participants with predefined non-atrial fibrillation arrhythmias, including third-degree atrioventricular block, frequent premature atrial contractions, and frequent premature ventricular contractions, as determined by the blinded ECG Core Laboratory.
Measured: From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Heart Rate Variability Parameters
Cardiac autonomic function will be assessed using time-domain and frequency-domain heart rate variability parameters obtained from electrocardiographic monitoring. Measurements will be centrally analyzed by the blinded ECG Core Laboratory.
Measured: During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). An EQ-5D-5L health utility index will be calculated using the Chinese population value set. The index ranges from -0.391 to 1.000, with higher scores indicating better health status. A score of 1.000 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
Measured: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Atrial Fibrillation-Related Quality of Life Assessed Using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire
Atrial fibrillation-related quality of life will be assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT). The AFEQT Overall Summary Score ranges from 0 to 100, with higher scores indicating better atrial fibrillation-related health status and quality of life and lower scores indicating greater impairment. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
Measured: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Reoperation for Bleeding
The proportion of participants who require surgical re-exploration because of postoperative bleeding.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Postoperative Blood Transfusion
The proportion of participants who receive a blood transfusion after surgery during the index hospitalization.
Measured: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Delayed Moderate or Greater Pericardial Effusion
The proportion of participants who develop new-onset moderate or greater pericardial effusion within 30 days after discharge from the index hospitalization, as documented by echocardiography.
Measured: From discharge from the index hospitalization through 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,470 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Mario Gaudino, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918781
- Sponsor's protocol ID
- NCRC2026001
- Other IDs
- 2026-12M-SXZX1-05
- Acronym
- CALM
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Neuromodulation in Myocardial Revascularization (CALM): A Multicenter Randomized Controlled Trial of Partial Cardiac Denervation for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07918781
- Acronym / sponsor ID
- CALM / NCRC2026001
- Keywords
- Postoperative Atrial Fibrillation, Coronary Artery Bypass Grafting, Partial Cardiac Denervation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,470 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Nov 2026 (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.
Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery and is associated with increased risks of mortality, stroke, myocardial infarction, and hospital readmission. The cardiac autonomic nervous system plays an important role in the development of POAF and may represent a potential target for preventive intervention.
The CALM trial is a multicenter, randomized controlled trial designed to evaluate the efficacy and safety of partial cardiac denervation for the prevention of POAF in patients undergoing isolated coronary artery bypass grafting (CABG). A total of approximately 1,470 participants will be randomly assigned in a 1:1 ratio to undergo CABG with partial cardiac denervation or CABG alone. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.
The trial will evaluate the incidence of POAF within the first 6 postoperative days and the occurrence of long-term adverse clinical events. Participants will undergo scheduled rhythm monitoring and clinical follow-up, and all participants will be followed until the last enrolled participant completes 3 years of follow-up after surgery.
Detailed description
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass grafting (CABG) and is associated with increased risks of stroke, myocardial infarction, prolonged hospitalization, and other adverse outcomes. Autonomic imbalance and excessive activation of the intrinsic cardiac autonomic nervous system are considered important contributors to the development of POAF. Previous studies of pharmacological or biological autonomic modulation have shown variable efficacy, and their effects may be transient.
A previous single-center randomized trial conducted by the investigators showed that partial cardiac denervation, consisting of transection of the ligament of Marshall and resection of the Waterston fat pad, reduced the incidence of POAF after CABG without increasing perioperative complications. The CALM trial is designed to evaluate whether these findings can be reproduced across multiple centers and to investigate the potential long-term clinical and autonomic effects of this intervention.
This is a prospective, multicenter, randomized controlled trial involving approximately 1,470 patients undergoing isolated CABG with or without cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to partial cardiac denervation in addition to standard CABG or to standard CABG alone. Centralized randomization will be stratified by participating center and baseline CHA2DS2-VASc score. Treatment allocation will be disclosed to the operating surgeon only after induction of anesthesia. Participants, outcome assessors, electrocardiographic reviewers, clinical event adjudicators, and statisticians will remain blinded to treatment allocation.
In the intervention group, the ligament of Marshall, located between the left atrial appendage and the left pulmonary veins, will be transected using electrocautery. The Waterston fat pad, located in the interatrial groove between the right atrium and the right pulmonary veins, will then be completely resected down to the epicardial surface. No additional denervation procedure will be performed in the control group. Other aspects of CABG and perioperative care will follow routine clinical practice at each participating center.
Continuous electrocardiographic monitoring will be performed during the early postoperative period, and scheduled ambulatory electrocardiographic monitoring will be conducted during follow-up. Electrocardiographic recordings will be centrally reviewed by an independent ECG Core Laboratory. Suspected clinical endpoint events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Participants will undergo scheduled clinical follow-up for assessment of arrhythmias, cardiac autonomic function, and long-term clinical outcomes. All participants will be followed until the last enrolled participant has completed 3 years of follow-up after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –CABG alone |
| Intervention group | Experimental | Procedure: Partial Cardiac DenervationPartial cardiac denervation + CABG. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled to undergo isolated coronary artery bypass grafting, either with or without cardiopulmonary bypass.
- Able and willing to provide written informed consent.
- No atrial fibrillation detected on preoperative 24-hour electrocardiographic monitoring.
Key exclusion criteria (8 listed)
- Previous cardiac surgery.
- Emergency surgery.
- Preoperative critical condition.
- Left ventricular ejection fraction of 30% or lower.
- Left atrial diameter greater than 50 mm.
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 |
|---|---|---|
| Partial Cardiac DenervationThe intervention has been described in previous studies. Briefly, intraoperative partial cardiac denervation is achieved by transection of the left LOM and resection of the right Waterston fat pad using electrocautery. During the procedure, the pulmonary trunk is first gently retracted to the right to expose the LOM located between the left atrial appendage and the left pulmonary veins. The LOM is then transected using electrocautery. Subsequently, the right atrium is retracted to the left to expose the Waterston fat pad located in the interatrial groove. The Waterston fat pad is completely excised with electrocautery down to the epicardial surface. | Procedure or surgery | Intervention group |
Primary outcome
Incidence of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Time frame: From admission to the intensive care unit after surgery until postoperative day 6.
The proportion of participants with documented new-onset postoperative atrial fibrillation (POAF). POAF is defined as an episode of atrial fibrillation characterized by irregularly irregular RR intervals and the absence of discernible P waves, lasting more than 30 seconds. Continuous electrocardiographic recordings will be centrally reviewed by the blinded ECG Core Laboratory.
Time to First Occurrence of the Composite Clinical Outcome
Time frame: From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.
Time from surgery to the first occurrence of any component of the composite outcome, including all-cause death, stroke, systemic embolism, myocardial infarction, readmission for cardiac reasons, or post-discharge atrial fibrillation. Suspected clinical events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Post-discharge atrial fibrillation events will be reviewed by the blinded ECG Core Laboratory.
17 secondary outcomes
Postoperative Length of Hospital Stay
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Total Hospitalization Costs
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative All-Cause Mortality
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative New-Onset Stroke
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative Myocardial Infarction
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Postoperative Atrial Fibrillation Burden Within 6 Postoperative Days
Time frame: From admission to the intensive care unit after surgery until postoperative day 6.
Number of Postoperative Atrial Fibrillation Episodes Within 6 Postoperative Days
Time frame: From admission to the intensive care unit after surgery until postoperative day 6.
Duration of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Time frame: From admission to the intensive care unit after surgery until postoperative day 6.
Incidence of Post-Discharge Atrial Fibrillation
Time frame: From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Post-Discharge Atrial Fibrillation Burden
Time frame: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Non-Atrial Fibrillation Arrhythmias
Time frame: From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Heart Rate Variability Parameters
Time frame: During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Time frame: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Atrial Fibrillation-Related Quality of Life Assessed Using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire
Time frame: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Reoperation for Bleeding
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Postoperative Blood Transfusion
Time frame: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Delayed Moderate or Greater Pericardial Effusion
Time frame: From discharge from the index hospitalization through 30 days after discharge.
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
Mario Gaudino, M.D. principal investigator
Weill Medical College of Cornell University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Cardiac Denervation in people with Postoperative Atrial Fibrillation and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 5 sites 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Ziang Yang, M.D. (86+19801109287, yzang47@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Atrial Fibrillation Within 6 Postoperative Days (time frame: From admission to the intensive care unit after surgery until postoperative day 6.). The study lists 2 primary outcomes in all. 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 5 Nov 2026.