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IRCT20230809059099N2 IRCT 2024-03-01 Avecinna co Efficacy and safety of Iranian Avecinna co. defibrillator Efficacy and safety of the Defibrillator / Monitor model Re-pulse6 Avecinna Co. among patients with atrial fibrillation and flutter who are candidates of elective cardioversion: a stratified non-inferiority randomized controlled trial at Tehran Heart Center 2024-03-05 anticipated 105 Complete https://irct.ir/trial/74128 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized using stratified method to re-pulse6 and standard defibrillator (Life Pack 20) groups. randomization code will be assigned after the patient is officially enrolled in the study and there will be no blinding. N/A Atrial fibrillation, atrial flutter. Intervention 1: Intervention group: Avecinna defibrillator. In both groups patients will be sedated. antiarhythmic drug use will be recorded in CRF forms. anti-arrhythmic drugs will not be used as pretreatment in cardiversion. Continuous ECG monitoring will be performed for all patients. In all patients biphasic waves and anteriorleft lateral sticking patches will be used. electrodes will be placed in the anterior in the middle of the sternum and in the posterior in the medial and inferior to the left scapula. in atrial fibrillation patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 100, 200, and 300 joules. In atrial flutter patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 50, 100, and 200 joules. If sinus rhythm is not achieved after three shockwaves treatment failure will be announced. Patients with treatment failure will be removed from the study and their treatment will be based on the cardiologist's discretion. all adverse events and outcomes will be recorded before and after cardioversion. Intervention 2: Control group: standard defibrillator (LIFE PACK 20). In both groups patients will be sedated. antiarhythmic drug use will be recorded in CRF forms. anti-arrhythmic drugs will not be used as pretreatment in cardiversion. Continuous ECG monitoring will be performed for all patients. In all patients biphasic waves and anteriorleft lateral sticking patches will be used. electrodes will be placed in the anterior in the middle of the sternum and in the posterior in the medial and inferior to the left scapula. in atrial fibrillation patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 100, 200, and 300 joules. In atrial flutter patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 50, 100, and 200 joules. If sinus rhythm is not achieved after three shockwaves treatment failure will be announced. Patients with treatment failure will be removed from the study and their treatment will be based on the cardiologist's discretion. all adverse events and outcomes will be recorded before and after cardioversion. Yes - There is a plan to make this available What will be shared: only a part of the data such as the primary outcomes will be shared When: after completion of the study To whom: for scientific community Conditions: documents will be shared upon reasonable request Where to obtain: from cardiovascular diseases esearch institute How to obtain: please email farzad masoudkabir. farzad.masoudkabir@gmail.com Comments:
public Farzad Masoud Kabir
Department of Cardiovascular Research, Tehran Heart Center, North Kargar Ave, Tehran, 1411713138
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 farzad.masoudkabir@gmail.com Tehran University of Medical Sciences scientific Farzad Masoud Kabir
Department of Cardiovascular Research, Tehran Heart Center, North Kargar Ave, Tehran, 1411713138, Iran.
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 farzad.masoudkabir@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age >18 years old Atrial fibrillation or flutter indication for cardioversion Atrial fibrillation or flutter will be confirmed by an electrophysiologist using 12 lead standard ECG. Cardioversion will be conducted at the discretion of the electrophysiologist. All patients are required to receive at least 4 weeks of antio coagulation or left atrial thrombus is ruled out by trans esophageal echocardiography 18 years 90 years Both Requiring emergeny cardioversion Hemodynamic instability Chest pain or suspicion of acute coronary syndrome Hypokalemia Digoxin toxicity Pregnancy or breastfeeding No informed consent I48 Atrial fibrillation and flutter Treatment - Devices Treatment - Devices Intervention group: Avecinna defibrillator. In both groups patients will be sedated. antiarhythmic drug use will be recorded in CRF forms. anti-arrhythmic drugs will not be used as pretreatment in cardiversion. Continuous ECG monitoring will be performed for all patients. In all patients biphasic waves and anteriorleft lateral sticking patches will be used. electrodes will be placed in the anterior in the middle of the sternum and in the posterior in the medial and inferior to the left scapula. in atrial fibrillation patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 100, 200, and 300 joules. In atrial flutter patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 50, 100, and 200 joules. If sinus rhythm is not achieved after three shockwaves treatment failure will be announced. Patients with treatment failure will be removed from the study and their treatment will be based on the cardiologist's discretion. all adverse events and outcomes will be recorded before and after cardioversion. Control group: standard defibrillator (LIFE PACK 20). In both groups patients will be sedated. antiarhythmic drug use will be recorded in CRF forms. anti-arrhythmic drugs will not be used as pretreatment in cardiversion. Continuous ECG monitoring will be performed for all patients. In all patients biphasic waves and anteriorleft lateral sticking patches will be used. electrodes will be placed in the anterior in the middle of the sternum and in the posterior in the medial and inferior to the left scapula. in atrial fibrillation patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 100, 200, and 300 joules. In atrial flutter patients three biphasic shock waves will be used until the sinus rhythm is achieved. the order of the shocks will be as follows: 50, 100, and 200 joules. If sinus rhythm is not achieved after three shockwaves treatment failure will be announced. Patients with treatment failure will be removed from the study and their treatment will be based on the cardiologist's discretion. all adverse events and outcomes will be recorded before and after cardioversion. Rate of sinus rhythm conversion. Timepoint: After cardioversion. Method of measurement: ECG. Number of times shock is required in experimental and standard device. Timepoint: After start of the cardioversion process. Method of measurement: Number. Safety: any inflammation, burn, pain, or electrocution in experimental device compared to standard device. comparison of ventricular arrhythmias, bradycardia, or asystole.comparison of any other adverse effects. Timepoint: Immeadiately after shock. Method of measurement: Observation by the cardiologist. Avecinna co Approved 2023-08-06 Tehran University of Medical Sciences, Ethics Committee Department of Cardiovascular Research, Tehran Heart Center, North Kargar Ave, Tehran, tehran Tehran Iran (Islamic Republic of)