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

NCT07755072 | Not Yet Recruiting

• 1 other identifier: IRB00006761-M20260425
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints

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

  During the postoperative hospital stay

Secondary Outcomes (1)

• Secondary Endpoints

  Postoperative month 1

Study Arms (2)

MICS-CABG combined with excision of the Ligament of Marshall

EXPERIMENTAL

Procedure: MICS-CABG combined with excision of the Ligament of Marshall

MICS-CABG without excision of the Ligament of Marshall

NO INTERVENTION

Interventions

MICS-CABG combined with excision of the Ligament of Marshall PROCEDURE

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.

MICS-CABG combined with excision of the Ligament of Marshall

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (23)

• 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.

  PMID: 33107945 RESULT

• 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.

  PMID: 33781979 RESULT

• 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.

  PMID: 11028490 RESULT

• 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.

  PMID: 16836704 RESULT

• 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.

  PMID: 39550720 RESULT

• 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.

  PMID: 34788640 RESULT

• 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.

  PMID: 30792496 RESULT

• 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.

  PMID: 28011843 RESULT

• 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.

  PMID: 38033089 RESULT

• 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.

  PMID: 34325516 RESULT

• 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.

  PMID: 36590740 RESULT

• 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.

  PMID: 23040194 RESULT

• 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.

  PMID: 37726512 RESULT

• 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.

  PMID: 19017662 RESULT

• 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.

  PMID: 30071562 RESULT

• Eikelboom R, Sanjanwala R, Le ML, Yamashita MH, Arora RC. Postoperative Atrial Fibrillation After Cardiac Surgery: A Systematic Review and Meta-Analysis. Ann Thorac Surg. 2021 Feb;111(2):544-554. doi: 10.1016/j.athoracsur.2020.05.104. Epub 2020 Jul 17.

  PMID: 32687821 RESULT

• Benedetto U, Gaudino MF, Dimagli A, Gerry S, Gray A, Lees B, Flather M, Taggart DP; ART Investigators*. Postoperative Atrial Fibrillation and Long-Term Risk of Stroke After Isolated Coronary Artery Bypass Graft Surgery. Circulation. 2020 Oct 6;142(14):1320-1329. doi: 10.1161/CIRCULATIONAHA.120.046940. Epub 2020 Oct 5.

  PMID: 33017213 RESULT

• LaPar DJ, Speir AM, Crosby IK, Fonner E Jr, Brown M, Rich JB, Quader M, Kern JA, Kron IL, Ailawadi G; Investigators for the Virginia Cardiac Surgery Quality Initiative. Postoperative atrial fibrillation significantly increases mortality, hospital readmission, and hospital costs. Ann Thorac Surg. 2014 Aug;98(2):527-33; discussion 533. doi: 10.1016/j.athoracsur.2014.03.039.

  PMID: 25087786 RESULT

• Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.

  PMID: 24183338 RESULT

• Zoupas I, Manaki V, Tasoudis PT, Karela NR, Avgerinos DV, Mylonas KS. Totally Endoscopic Coronary Artery Bypass Graft: Systematic Review and Meta-Analysis of Reconstructed Patient-Level Data. Innovations (Phila). 2024 Nov-Dec;19(6):616-625. doi: 10.1177/15569845241296530. Epub 2024 Nov 20.

  PMID: 39567250 RESULT

• Phan K, Ha HS, Phan S, Medi C, Thomas SP, Yan TD. New-onset atrial fibrillation following coronary bypass surgery predicts long-term mortality: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2015 Dec;48(6):817-24. doi: 10.1093/ejcts/ezu551. Epub 2015 Jan 18.

  PMID: 25602053 RESULT

• Filardo G, Damiano RJ Jr, Ailawadi G, Thourani VH, Pollock BD, Sass DM, Phan TK, Nguyen H, da Graca B. Epidemiology of new-onset atrial fibrillation following coronary artery bypass graft surgery. Heart. 2018 Jun;104(12):985-992. doi: 10.1136/heartjnl-2017-312150. Epub 2018 Jan 11.

  PMID: 29326112 RESULT

• Lubitz SA, Yin X, Rienstra M, Schnabel RB, Walkey AJ, Magnani JW, Rahman F, McManus DD, Tadros TM, Levy D, Vasan RS, Larson MG, Ellinor PT, Benjamin EJ. Long-term outcomes of secondary atrial fibrillation in the community: the Framingham Heart Study. Circulation. 2015 May 12;131(19):1648-55. doi: 10.1161/CIRCULATIONAHA.114.014058. Epub 2015 Mar 13.

  PMID: 25769640 RESULT

Central Study Contacts

Yunpeng Ling

CONTACT

+8615611963466; micsling@pku.edu.cn

Jian Song

CONTACT

songjianeric@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: August 10, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-06

Locations

CN (1)