Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05780320
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative atrial fibrillation', 'timeFrame': 'Prior to patient discharge or within 30 days after surgery.', 'description': 'At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.'}], 'secondaryOutcomes': [{'measure': 'Operative mortality', 'timeFrame': 'Either in-hospital death or death within 30 days of discharge', 'description': 'Operative mortality as defined by either in-hospital death or death within 30 days of discharge.'}, {'measure': 'Stroke', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'Characterized by deficits lasting \\> 24 hours and/or imaging findings of infarction'}, {'measure': 'Transient ischemic attack', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'Characterized by examination findings lasting \\< 24 hours without associated imaging findings'}, {'measure': 'Initiation of systemic anticoagulation', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation'}, {'measure': 'Persistence of atrial fibrillation at discharge', 'timeFrame': 'At postoperative surgical visit (around 4-6 weeks)', 'description': 'Atrial fibrillation as diagnosed by final ECG'}, {'measure': 'Postoperative hospital length of stay', 'timeFrame': 'Up to 90 days', 'description': 'The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge'}, {'measure': 'Readmission', 'timeFrame': 'Within 30 days of procedure', 'description': 'Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.'}, {'measure': 'Symptomatic bradycardia', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'Symptomatic bradycardia (HR \\< 55 bpm) requiring intervention'}, {'measure': 'Number of patients with Amiodarone-related pulmonary toxicity', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.'}, {'measure': 'Postoperative pleural effusions requiring intervention', 'timeFrame': 'Either in-hospital or within 30 days of procedure', 'description': 'Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative atrial fibrillation'], 'conditions': ['Atrial Fibrillation New Onset']}, 'referencesModule': {'references': [{'pmid': '28369234', 'type': 'BACKGROUND', 'citation': 'Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.'}, {'pmid': '23440790', 'type': 'BACKGROUND', 'citation': 'Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3.'}, {'pmid': '23627761', 'type': 'BACKGROUND', 'citation': 'Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29.'}, {'pmid': '17316148', 'type': 'BACKGROUND', 'citation': 'Buckley MS, Nolan PE Jr, Slack MK, Tisdale JE, Hilleman DE, Copeland JG. Amiodarone prophylaxis for atrial fibrillation after cardiac surgery: meta-analysis of dose response and timing of initiation. Pharmacotherapy. 2007 Mar;27(3):360-8. doi: 10.1592/phco.27.3.360.'}, {'pmid': '31447894', 'type': 'BACKGROUND', 'citation': 'Colunga Biancatelli RM, Congedo V, Calvosa L, Ciacciarelli M, Polidoro A, Iuliano L. Adverse reactions of Amiodarone. J Geriatr Cardiol. 2019 Jul;16(7):552-566. doi: 10.11909/j.issn.1671-5411.2019.07.004.'}, {'pmid': '19597088', 'type': 'BACKGROUND', 'citation': 'Orr CF, Ahlskog JE. Frequency, characteristics, and risk factors for amiodarone neurotoxicity. Arch Neurol. 2009 Jul;66(7):865-9. doi: 10.1001/archneurol.2009.96.'}, {'pmid': '19399307', 'type': 'BACKGROUND', 'citation': 'Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540.'}, {'pmid': '34788640', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all patients undergoing coronary artery bypass cardiac surgery at the Massachusetts General Hospital who meets the above criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preoperative normal sinus rhythm\n* Procedures:\n* CABG\n* CABG + concomitant valve or aortic replacement/repair\n\nExclusion Criteria:\n\n* Emergent operation\n\nProcedures:\n\n* MAZE or PVI performed\n* Isolated valve replacement or repair\n* Isolated aortic procedures\n* Heart transplant\n* Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use\n* PR interval \\> 240 ms\n* 2nd or 3rd degree heart block\n* QTc \\> 550ms\n* 2nd or 3rd degree heart block\n* Liver impairment (INR \\> 1.7, AST/ALT \\> 2x normal)\n* Uncontrolled hypothyroidism/hyperthyroidism\n* Interstitial lung disease\n* Allergy to amiodarone'}, 'identificationModule': {'nctId': 'NCT05780320', 'briefTitle': 'A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery', 'orgStudyIdInfo': {'id': '2004P001528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pharmaco-Surgical Arm', 'interventionNames': ['Other: Prophylactic amiodarone and posterior pericardiotomy']}, {'label': 'Standard of Care Arm'}], 'interventions': [{'name': 'Prophylactic amiodarone and posterior pericardiotomy', 'type': 'OTHER', 'description': 'Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.\n\nThe amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.\n\nThe posterior pericardiotomy occurs during the cardiac procedure.', 'armGroupLabels': ['Pharmaco-Surgical Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Asishana A Osho, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Asishana A Osho', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}