Atrial FibrillationNCT06553391
Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis
An observational study of Atrial Fibrillation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- The tetralogy of medication regimen
- Type of treatment
- Injection or infusion
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 May 2025
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with atrial fibrillationwho were scheduled for elective cardiac surgery under general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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 \<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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518058
About this study
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.
Read the detailed description
Background: Most patients with atrial fibrillation (AF) continue to experience AF following cardiac surgery, which is not conducive to postoperative circulatory stability. Intraoperative active cardioversion has rarely studied due to uncertainty regarding the efficacy of pharmacological cardioversion and the recurrence rate of AF in patients with persistent AF.
Objective: To assess the effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF.
Methods: 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 AF who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study. These patients undergoing pharmacological cardioversion during surgery were matched with untreated patients in a 1:1 ratio based on age, sex, weight, diagnosis, beta blocker and digoxin usage, indicators from cardiac ultrasound and blood gas analysis. 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. The choice between these drugs depends on the patient's blood pressure and heart rate. The incidence of cardioversion in patients who underwent the tetralogy of medication regimen approach was compared with that of untreated patients.
- Conditions
- Atrial Fibrillation
- Being tested
- The tetralogy of medication regimen
- Keywords
- atrial fibrillation, pharmacological cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tetralogy of medication regimenDrug
Also called aminophylline, ephedrine, isoproterenol, amiodarone
During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating：
- 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.
- 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.
- 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) .
- In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: The tetralogy of medication regimen | |
| Control group | Patients in the control group did not receive treatment with antiarrhythmic drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm
Electrocardiogram monitoring
Measured: From the release of the aortic cross-clamp until 12 hours after surgery
Secondary outcomes (2)
Mean arterial pressure
Invasive arterial blood pressure test
Measured: From the release of the aortic cross-clamp until the end of surgery
the use of temporary pacemakers
Postoperative record
Measured: From the release of the aortic cross-clamp until 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Jan 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Linlin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- linlin chen, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553391
- Sponsor's protocol ID
- SP2023036（01）
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analytical data from this study was shared upon the completion of the research. Individuals who wish to access the data are required to declare their intended use for it. Contact information for the person responsible for managing the data can be obtained from the ClinicalTrials.gov PRS website.
Publications
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.
PubMed 31109634Colilla 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.
PubMed 23831166Tarantini 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.
PubMed 27085579Weng 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.
PubMed 29129827Santhanakrishnan 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.
PubMed 26746177Kamal 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.
PubMed 36052897