Clinical trial NCT03716934: CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
Official title: CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent persistent atrial fibrilation

Exclusion Criteria:

* Patients with atrial fibrilation for more than one year at baseline
* Atrial fibrilation prior ablation
* Age\> 75 years or \<18 years
* Hyperthyroidism
* Hypertrophic cardiomyopathy
* Severe valvular disease (stenosis or regurgitation)
* Carriers of cardiac valves
* Anteroposterior diameter of left atrium\> 50 mm (left parasternal long axis)
* Contraindications for anticoagulation
* Left atrial thrombus
* Anemia
* Active infection
* Pregnancy
* Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)
* Life expectancy of less than 24 months
* Participation in another non-purely observational study
* Patients unable to understand treatment and / or study and / or providing adequate informed consent
* Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study
* Microalbuminemia

Primary outcomes:
measure: Survival time with atrial fibrilation, auricular flutter or tachycardia
timeFrame: Up to 9 months.
measure: Presence of death or one major complications.
timeFrame: first month
measure: Presence of death or one major complications.
timeFrame: fourth month
measure: Presence of death or one major complications.
timeFrame: thirteen month
Secondary outcomes:
measure: Percentage of patients without atrial fibrilation, flutter or tachycardia
timeFrame: first month
measure: Percentage of patients without atrial fibrilation, flutter or tachycardia
timeFrame: fourth month
measure: Percentage of patients without atrial fibrilation, flutter or tachycardia
timeFrame: thirteen month
measure: Percentage of patient with cardioversion
timeFrame: first month
measure: Percentage of patient with cardioversion
timeFrame: fourth month
measure: Percentage of patient with cardioversion
timeFrame: thirteen month
measure: Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
timeFrame: first month
measure: Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
timeFrame: fourth month
measure: Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events
timeFrame: thirteen month
measure: Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
timeFrame: first month
measure: Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
timeFrame: fourth month
measure: Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency
timeFrame: thirteen month
measure: Percentage of patient with need for ablation or re-ablation not scheduled
timeFrame: first month
measure: Percentage of patient with need for ablation or re-ablation not scheduled
timeFrame: fourth month
measure: Percentage of patient with need for ablation or re-ablation not scheduled
timeFrame: thirteen month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Study officials:
References: