CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
NCT ID: NCT03716934
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
196 participants
INTERVENTIONAL
2018-06-27
2022-04-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cryoablation
Cryoablation for bidirectional block of all pulmonary veins
Arctic Front Advance® balloon catheter
Cryoablation of bidirectional block of all pulmonary veins
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
Antiarrythmics
The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.
Antiarrhythmic drug
The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.
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
Interventions
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Arctic Front Advance® balloon catheter
Cryoablation of bidirectional block of all pulmonary veins
Antiarrhythmic drug
The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Nicasio Perez Castellano
Principal Investigator
Locations
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Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Madrid, Spain
Countries
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Other Identifiers
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17/507-R_M
Identifier Type: -
Identifier Source: org_study_id
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