Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

NCT06553391 | Completed DMC

• 1 other identifier: SP2023036（01）
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is: Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pharmacological cardioversion

Outcome Measures

Primary Outcomes (1)

• Sinus rhythm

  Electrocardiogram monitoring

  From the release of the aortic cross-clamp until 12 hours after surgery

Secondary Outcomes (2)

• Mean arterial pressure

  From the release of the aortic cross-clamp until the end of surgery

• the use of temporary pacemakers

  From the release of the aortic cross-clamp until 12 hours after surgery

Study Arms (2)

TMR group

The treatment regimen for the tetralogy of medication regimen group (TMR group）commences with the administration of amiodarone during rewarming. In the event of cardiac relapse, a combination of the following drugs may be utilized: aminophylline, ephedrine, and isoproterenol. The selection of these medications is contingent upon the patient's blood pressure and heart rate.

Drug: The tetralogy of medication regimen

Control group

Patients in the control group did not receive treatment with antiarrhythmic drugs.

Interventions

The tetralogy of medication regimen DRUG

During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating： 1. If the heart rate is ≥70 beats per minute without specific therapy and in sinus rhythm or atrioventricular junctional rhythm, no special treatment is required. If the heart rate \<70 beats/min, intravenous injection of isoproterenol 2 ug may be administered. 2. In cases where there is sinus rhythm or atrioventricular junctional rhythm with a heart rate \<70 beats/min and perfusion pressure \<60mmHg, intravenous injection of ephedrine 10 mg + aminophylline 0.15 g should be given. 3. For patients with atrioventricular junctional rhythm or sinus rhythm and a heart rate \<70 beats/min but perfusion pressure ≥60mmHg, intravenous injections of aminophylline (0.15g) and ephedrine (10 mg) . 4. In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.

Also known as: aminophylline, ephedrine, isoproterenol, amiodarone

TMR group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillationwho were scheduled for elective cardiac surgery under general anesthesia

You may qualify if:

• ASA Ⅱ-Ⅲ,
• Aged 18-70 years,
• Who were scheduled for elective cardiac surgery under general anesthesia,
• Who were diagnosed with atrial fibrillation by preoperative 12-lead electrocardiogram or 24-hour holter electrocardiogram.

You may not qualify if:

• Allergic to iodine, amiodarone or its excipients
• Pulmonary fibrosis
• Keratopathy or severe loss of vision or blindness
• Patients with sick sinus syndrome, severe bradycardia (heart rate \&lt;50bpm), second- or higher-degree atrioventricular block
• Preoperative intravenous infusion of amiodarone
• Intraoperative radiofrequency ablation of atrial fibrillation
• The patient is participating in another interventional clinical study.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, 518058, China

Location

Related Publications (6)

• Noubiap JJ, Bigna JJ, Agbor VN, Mbanga C, Ndoadoumgue AL, Nkeck JR, Kamguia A, Nyaga UF, Ntusi NAB. Meta-analysis of Atrial Fibrillation in Patients With Various Cardiomyopathies. Am J Cardiol. 2019 Jul 15;124(2):262-269. doi: 10.1016/j.amjcard.2019.04.028. Epub 2019 Apr 24.

  PMID: 31109634 BACKGROUND

• Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

  PMID: 23831166 BACKGROUND

• Tarantini G, Mojoli M, Windecker S, Wendler O, Lefevre T, Saia F, Walther T, Rubino P, Bartorelli AL, Napodano M, D'Onofrio A, Gerosa G, Iliceto S, Vahanian A. Prevalence and Impact of Atrial Fibrillation in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement: An Analysis From the SOURCE XT Prospective Multicenter Registry. JACC Cardiovasc Interv. 2016 May 9;9(9):937-46. doi: 10.1016/j.jcin.2016.01.037. Epub 2016 Apr 13.

  PMID: 27085579 BACKGROUND

• Weng LC, Preis SR, Hulme OL, Larson MG, Choi SH, Wang B, Trinquart L, McManus DD, Staerk L, Lin H, Lunetta KL, Ellinor PT, Benjamin EJ, Lubitz SA. Genetic Predisposition, Clinical Risk Factor Burden, and Lifetime Risk of Atrial Fibrillation. Circulation. 2018 Mar 6;137(10):1027-1038. doi: 10.1161/CIRCULATIONAHA.117.031431. Epub 2017 Nov 12.

  PMID: 29129827 BACKGROUND

• Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.

  PMID: 26746177 BACKGROUND

• Kamal F, Abd Al Jawad MN, Gamal M. Efficacy of Intraoperative Low Dose Intravenous Amiodarone in Pharmacologic Cardioversion in Patients with Preoperative Atrial Fibrillation Presenting for Mitral Valve Replacement Surgery Randomized Control Trial. Heart Surg Forum. 2022 Jul 27;25(4):E564-E570. doi: 10.1532/hsf.4901.

  PMID: 36052897 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Aminophylline; Ephedrine; Isoproterenol; Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines; Ethanolamines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzofurans

Study Officials

• linlin chen

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be made available after the study, with no deadline.
• Access Criteria: Visitors must obtain permission from the study leader and declare the purpose of their data.

Locations

CN (1)