This is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of PVs using the Arctic Front Advance® balloon catheter with antiarrhythmic therapy in patients with persistent AF.
The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients. The symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. Pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. Different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. Frequents monitoring periods provide the information of the heart rate and the effect of any intervention. The "Confirm RX heart monitor® (Abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. This implantable Holter automatically detects and saves atrial and ventricular arrhythmic episodes. The device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options. This is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the Arctic Front Advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
196
Cryoablation of bidirectional block of all pulmonary veins
The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.
Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Madrid, Spain
Survival time with atrial fibrilation, auricular flutter or tachycardia
Survival time without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes duration detected by Holter
Time frame: Up to 9 months.
Presence of death or one major complications.
Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.
Time frame: first month
Presence of death or one major complications.
Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.
Time frame: fourth month
Presence of death or one major complications.
Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of VP, Sustained (\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.
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Time frame: thirteen month
Percentage of patients without atrial fibrilation, flutter or tachycardia
Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes
Time frame: first month
Percentage of patients without atrial fibrilation, flutter or tachycardia
Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes
Time frame: fourth month
Percentage of patients without atrial fibrilation, flutter or tachycardia
Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes
Time frame: thirteen month
Percentage of patient with cardioversion
Number of patients that need cardioversion
Time frame: first month
Percentage of patient with cardioversion
Number of patients that need cardioversion
Time frame: fourth month
Percentage of patient with cardioversion
Number of patients that need cardioversion
Time frame: thirteen month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events
Time frame: first month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events
Time frame: fourth month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events
Time frame: thirteen month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
Number of patients that need a change or suspension of antiarrhythmic due to inefficiency
Time frame: first month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
Number of patients that need a change or suspension of antiarrhythmic due to inefficiency
Time frame: fourth month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
Number of patients that need a change or suspension of antiarrhythmic due to inefficiency
Time frame: thirteen month
Percentage of patient with need for ablation or re-ablation not scheduled
Number of patients that need a ablation or re-ablation not scheduled
Time frame: first month
Percentage of patient with need for ablation or re-ablation not scheduled
Number of patients that need a ablation or re-ablation not scheduled
Time frame: fourth month
Percentage of patient with need for ablation or re-ablation not scheduled
Number of patients that need a ablation or re-ablation not scheduled
Time frame: thirteen month