AzTrials
AzTrials

Postoperative Atrial FibrillationNCT07755072

The Effect of Ligament of Marshall Excision During Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting (MICS-CABG) on the Prevention of Postoperative New-Onset Atrial Fibrillation: A Multicenter, Prospective, Randomized, Triple-Blinded Study

A study testing MICS-CABG combined with excision of the Ligament of Marshall in people with Postoperative Atrial Fibrillation, run by Peking University Third Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

After heart bypass surgery, many patients develop a heart rhythm problem called postoperative atrial fibrillation, or POAF for short. This issue happens to 20%-40% of all bypass patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postoperative Atrial Fibrillation
What is being tested?
MICS-CABG combined with excision of the Ligament of Marshall
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
628 participants
Where
1 siteChina
Study dates
13 Jul 2026to 31 Jan 2028
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-80 years;
  • Coronary artery lesions meeting the indications for surgical revascularization, with planned MICS-CABG;
  • Signed an informed consent form agreeing to participate in the study;

Who cannot join

  • Patients with preoperative hemodynamic instability requiring emergency surgery;
  • History of paroxysmal or persistent atrial fibrillation prior to surgery;
  • Echocardiographic left atrial anteroposterior diameter (APD) ≥ 60 mm;
  • Patients with ejection fraction (EF) < 40%, left ventricular diastolic dimension (LVDD) > 60 mm, left ventricular aneurysm, or severe arrhythmia who are at high risk of intraoperative hemodynamic instability;
  • Patients with concomitant mitral stenosis or regurgitation of moderate severity or greater;
  • Patients undergoing concurrent valve surgery or other intracardiac corrective procedures;
Show all 12Show fewer
  • Patients with a history of renal insufficiency;
  • Patients receiving intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) circulatory support preoperatively;
  • Patients taking antiarrhythmic drugs other than beta-blockers prior to surgery, such as propafenone or amiodarone;
  • History of cardiac or thoracic surgery;
  • Poor pulmonary function, with a preoperative arterial blood gas analysis oxygen partial pressure (PaO₂) < 60 mmHg at rest without oxygen supplementation;
  • Patients with a preoperative pacemaker implant;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Song contact

songjianeric@126.com

China1 site
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Yunpeng Ling, micsling@pku.edu.cn

Other trials in China

About this study

After heart bypass surgery, many patients develop a heart rhythm problem called postoperative atrial fibrillation, or POAF for short. This issue happens to 20%-40% of all bypass patients. Even with smaller, less invasive surgical cuts or robot-assisted heart bypass operations, between 4.8% and 18.4% of people still get POAF.

When POAF occurs, patients usually stay in the hospital longer and face higher medical bills. It also raises chances of serious complications like stroke, heart failure and heart attacks, and lowers long-term survival rates. Stopping POAF early is therefore key to helping patients recover better after surgery.

Read more

POAF comes from two main causes: personal health risks and stress from the surgery itself. Older age, high blood pressure, heart failure, lung disease, diabetes and overweight all make people more likely to develop irregular heart rhythms after an operation. Surgical trauma also plays a big role: cutting the breastbone, fluid building up around the heart, inflammation from heart-lung machines, pulling or stitching heart tissue, and unbalanced nerve signals during recovery can all spark POAF. Earlier studies have shown simple surgical adjustments can lower POAF risk safely, giving us a good basis to improve current surgery methods.

The Ligament of Marshall is a fibrous bundle-like structure left over from heart development before birth. Its special tissue structure makes it easy to trigger chaotic heart beats. It holds muscle tissue that creates looping abnormal electrical signals, plus nerve clusters that overactivate the body's stress response after surgery - this is a major cause of POAF. Doctors who fix irregular heart rhythms with catheter burns already target this ligament to stop repeat atrial fibrillation. Major heart surgery for long-term irregular heartbeats also routinely cuts this ligament without adding extra surgical risks.

Our study will collect real clinical data to deepen the understanding of POAF and partial denervation therapy. Cutting the Ligament of Marshall during minimally invasive cardiac surgery-coronary artery bypass grafting (MICS-CABG) is an easy, low-risk step with no extra risk of collateral injury. We hope this method can lower the chance of irregular heartbeats after surgery, reduce the need for rhythm-control drugs and their side effects, and help patients maintain stable heart function and better daily life right after surgery.

For MICS-CABG, doctors do not need extra complicated steps to see and cut the Ligament of Marshall. We only make a small cut between the ribs on the left chest. After pericardial incision and suspension, this fibrous bundle-like structure is clearly visible and simple to operate on. Compared with traditional open-heart surgery that splits the whole breastbone, this small-cut approach avoids rough handling of the left heart and lessens overall surgical stress on patients.

Being tested
MICS-CABG combined with excision of the Ligament of Marshall

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MICS-CABG combined with excision of the Ligament of MarshallProcedure or surgery

    This intervention refers to excision of the Ligament of Marshall performed during MICS-CABG. Patients in this group will undergo routine MICS-CABG plus this extra surgical excision.

Study groups in NCT07755072
Study groupRoleWhat they receive
MICS-CABG combined with excision of the Ligament of MarshallExperimentalNot described
Receives: Procedure: MICS-CABG combined with excision of the Ligament of Marshall
MICS-CABG without excision of the Ligament of MarshallNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoints

    Each episode of POAF lasting ≥30 seconds during the postoperative hospital stay.

    Measured: During the postoperative hospital stay

Secondary outcomes (1)
  1. Secondary Endpoints

    Burden of POAF; need for Class I and III antiarrhythmic drugs (Vaughan Williams classification) and electrical cardioversion; postoperative length of hospital stay; postoperative duration of mechanical ventilation; reoperation due to bleeding; Incidence of non-atrial fibrillation arrhythmias at 1 month postoperatively (wristband + central adjudication)

    Measured: Postoperative month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start13 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
628 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07755072
Sponsor's protocol ID
IRB00006761-M20260425
Status last verified
Jun 2026
First submitted
6 Jul 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Valderrabano M, Peterson LE, Swarup V, Schurmann PA, Makkar A, Doshi RN, DeLurgio D, Athill CA, Ellenbogen KA, Natale A, Koneru J, Dave AS, Giorgberidze I, Afshar H, Guthrie ML, Bunge R, Morillo CA, Kleiman NS. Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1620-1628. doi: 10.1001/jama.2020.16195.

    PubMed 33107945
  • Valderrabano M. Vein of Marshall ethanol infusion in the treatment of atrial fibrillation: From concept to clinical practice. Heart Rhythm. 2021 Jul;18(7):1074-1082. doi: 10.1016/j.hrthm.2021.03.032. Epub 2021 Mar 26.

    PubMed 33781979
  • Kim DT, Lai AC, Hwang C, Fan LT, Karagueuzian HS, Chen PS, Fishbein MC. The ligament of Marshall: a structural analysis in human hearts with implications for atrial arrhythmias. J Am Coll Cardiol. 2000 Oct;36(4):1324-7. doi: 10.1016/s0735-1097(00)00819-6.

    PubMed 11028490
  • Makino M, Inoue S, Matsuyama TA, Ogawa G, Sakai T, Kobayashi Y, Katagiri T, Ota H. Diverse myocardial extension and autonomic innervation on ligament of Marshall in humans. J Cardiovasc Electrophysiol. 2006 Jun;17(6):594-9. doi: 10.1111/j.1540-8167.2006.00375.x.

    PubMed 16836704
  • 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
  • Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.

    PubMed 34788640
  • Dobrev D, Aguilar M, Heijman J, Guichard JB, Nattel S. Postoperative atrial fibrillation: mechanisms, manifestations and management. Nat Rev Cardiol. 2019 Jul;16(7):417-436. doi: 10.1038/s41569-019-0166-5.

    PubMed 30792496
  • Mitrofanova LB, Orshanskaya V, Ho SY, Platonov PG. Histological evidence of inflammatory reaction associated with fibrosis in the atrial and ventricular walls in a case-control study of patients with history of atrial fibrillation. Europace. 2016 Dec;18(suppl 4):iv156-iv162. doi: 10.1093/europace/euw361.

    PubMed 28011843
  • Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.

    PubMed 38033089
  • Singleton MJ, Yuan Y, Dawood FZ, Howard G, Judd SE, Zakai NA, Howard VJ, Herrington DM, Soliman EZ, Cushman M. Multiple Blood Biomarkers and Stroke Risk in Atrial Fibrillation: The REGARDS Study. J Am Heart Assoc. 2021 Aug 3;10(15):e020157. doi: 10.1161/JAHA.120.020157. Epub 2021 Jul 30.

    PubMed 34325516
  • Fatehi Hassanabad A, Schoettler FI, Kent WDT, Adams CA, Holloway DD, Ali IS, Novick RJ, Ahsan MR, McClure RS, Shanmugam G, Kidd WT, Kieser TM, Fedak PWM, Deniset JF. Comprehensive characterization of the postoperative pericardial inflammatory response: Potential implications for clinical outcomes. JTCVS Open. 2022 Sep 27;12:118-136. doi: 10.1016/j.xjon.2022.09.003. eCollection 2022 Dec.

    PubMed 36590740
  • Mihos CG, Santana O, Lamas GA, Lamelas J. Incidence of postoperative atrial fibrillation in patients undergoing minimally invasive versus median sternotomy valve surgery. J Thorac Cardiovasc Surg. 2013 Dec;146(6):1436-41. doi: 10.1016/j.jtcvs.2012.09.009. Epub 2012 Oct 4.

    PubMed 23040194
  • Kikuchi Y, Saijo Y, Narita M, Shibagaki K, Okubo R, Kunioka S, Shirasaka T, Kamiya H. Post-cardiotomy pericardial effusion and postoperative atrial fibrillation risk. Int J Cardiovasc Imaging. 2022 Aug;38(8):1873-1879. doi: 10.1007/s10554-022-02560-9. Epub 2022 Mar 30.

    PubMed 37726512
  • Shrivastava R, Smith B, Caskey D, Reddy P. Atrial fibrillation after cardiac surgery: does prophylactic therapy decrease adverse outcomes associated with atrial fibrillation. J Intensive Care Med. 2009 Jan-Feb;24(1):18-25. doi: 10.1177/0885066608327178. Epub 2008 Nov 17.

    PubMed 19017662
  • Yamashita K, Hu N, Ranjan R, Selzman CH, Dosdall DJ. Clinical Risk Factors for Postoperative Atrial Fibrillation among Patients after Cardiac Surgery. Thorac Cardiovasc Surg. 2019 Mar;67(2):107-116. doi: 10.1055/s-0038-1667065. Epub 2018 Aug 2.

    PubMed 30071562

Questions about this trial

What is this clinical trial studying?

A study testing MICS-CABG combined with excision of the Ligament of Marshall in people with Postoperative Atrial Fibrillation, run by Peking University Third Hospital 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 3 inclusion and 12 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 10 Aug 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?

Contact Yunpeng Ling (+8615611963466, micsling@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoints (time frame: During the postoperative hospital stay). 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 NCT07755072, which also lists 23 linked publications.

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 10 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in