Clinical trial NCT06553391: Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis
Official title: Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
pharmacological cardioversion
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillationwho were scheduled for elective cardiac surgery under general anesthesia

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 March 7, 2023, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2000, and January 31, 2023, were included in the study.

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 March 7, 2023, to January 1, 2025. Patients diagnosed with AF who underwent cardiac surgery between June 1, 2000, and January 31, 2023, 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. Data analyses took place from March 1, 2024.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sinus rhythm
timeFrame: From the release of the aortic cross-clamp until 6 hours after surgery
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: From the release of the aortic cross-clamp until the end of surgery
measure: the use of temporary pacemakers
timeFrame: From the release of the aortic cross-clamp until 6 hours after surgery
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen
state: Guangdong
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: linlin chen
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.