Atrial Fibrillation Paroxysmal Clinical Trial
Official title:
Safety and Efficacy of Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction > 35%
Current guidelines for the cardioversion of paroxysmal Atrial Fibrillation at the Emergency Department do not prioritize between antiarrhythmic agents and do not consider the time taken for successful cardioversion. Furthermore, the use of flecainide -a class 1C antiarrhythmic agent- is contraindicated for the cardioversion of patients with revascularized coronary artery disease, as well as patients with ischemic cardiomyopathy and preserved ejection fraction. These recommendations stem from insufficient data, mainly from the CAST study. The present study is a prospective, multicentre, randomized clinical trial. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation at the Emergency Department, and to prove that the safety of flecainide is non-inferior to amiodarone, in patients with coronary artery disease without residual ischemia and ejection fraction over 35%. The secondary goals of the study are to prove the superiority of flecainide over amiodarone in the reduction of hospitalizations from the Emergency Department due to atrial fibrillation, in the time taken to achieve cardioversion, and to the reduction of the need to conduct electrical cardioversion. The study population will be all consecutive new-comers to the Emergency Department with primary diagnosis of paroxysmal atrial fibrillation and history of coronary artery disease without angina, without residual ischemia and with ejection fraction > 35%. The sample size will be 200 patients, who will be monitored for 30 days. At the Emergency Department, all patients will be under continuous ECG monitoring, and a 24-hour ECG device will also be placed (Holter). The patients will be randomized to the treatment group (flecainide) and the control group (amiodarone). Patients in both arms will stay at the ED for a total of 6 hours after therapy initiation. If no adverse events occur in this time, the patient will be discharged from the ED. Otherwise, the patient will be admitted to the hospital. At 24 hours, the patients will visit the study centre for physical examination, ECG, cardiac ultrasound, 24-hour ECG removal and adverse events evaluation. At 30 days, follow-up via phone calls will be conducted for the evaluation of the study outcomes and adverse events.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06085014 -
Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation
|
||
Recruiting |
NCT03724383 -
Atrial Fibrillation Lifestyle Project
|
N/A | |
Active, not recruiting |
NCT04544397 -
Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
|
||
Not yet recruiting |
NCT05940597 -
Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT04447300 -
Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.
|
N/A | |
Recruiting |
NCT05251545 -
Randomized Trial: High Power Short Duration Versus Ablation Index
|
N/A | |
Recruiting |
NCT05883631 -
RESOLVE-AF: Clinical Evaluation of the Ablacathâ„¢ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
|
N/A | |
Not yet recruiting |
NCT04600713 -
Physiotherapist-led Exercise Within Cardiac Rehabilitation and Paroxysmal Atrial Fibrillation and COVID-19.
|
N/A | |
Enrolling by invitation |
NCT05725187 -
Prospective Validation Study of AI-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation
|
||
Recruiting |
NCT04606693 -
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
|
N/A | |
Recruiting |
NCT05328882 -
Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation
|
||
Recruiting |
NCT04342312 -
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
|
||
Completed |
NCT03323099 -
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
|
N/A | |
Completed |
NCT05461859 -
Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.
|
||
Enrolling by invitation |
NCT04634461 -
The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.
|
||
Completed |
NCT04023461 -
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
|
Phase 4 | |
Recruiting |
NCT06392932 -
Esophageal Temperature During PVI Using Q-DOT Micro
|
N/A | |
Not yet recruiting |
NCT06364215 -
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05292209 -
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
|
Phase 2 | |
Completed |
NCT04511520 -
Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF
|
N/A |