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Sponsors and Collaborators: |
Hospital General Universitario Gregorio Marañon Centro Nacional de Investigación Cardiovascular (CNIC) |
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Information provided by: | Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00674401 |
The purpose of this study is to assess the value of ablation of high frequency sources following circumferential pulmonary veins isolation in patients with paroxysmal and chronic atrial fibrillation
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: Radiofrequency catheter ablation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation |
Estimated Enrollment: | 232 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
In patients with paroxysmal atrial fibrillation: Empirical pulmonary vein antrum circumferential isolation. In patients with persistent atrial fibrillation: Empirical circumferential PV antrum isolation w/out roof line. |
Procedure: Radiofrequency catheter ablation
Patients who meet the inclusion criteria will be randomized into one of 2 in the study:
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2: Active Comparator
In patients with paroxysmal atrial fibrillation: High frequency sites ablation in the LA. In patients with persistent atrial fibrillation: A combined approach involving pulmonary vein antrum isolation w/out roof line and high frequency sites ablation |
Procedure: Radiofrequency catheter ablation
Patients who meet the inclusion criteria will be randomized into one of 2 in the study:
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Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, accounts for one-third of arrhythmia hospitalizations and is associated with an increased risk of stroke, heart failure, and all-cause mortality. Moreover, there is an increasing AF prevalence due to aging of the population, a rising prevalence of chronic heart disease, and increased survival. Unfortunately, medications aimed at suppressing AF and maintaining sinus rhythm or at controlling ventricular rate are only marginally effective and may cause serious adverse effects. The limitations of pharmacologic treatment patterns have fuelled the development of new interventional strategies. Current techniques of AF ablation can achieve a 60-80% improvement in highly selected patients with medically refractory AF. However, the procedure is not without risk, is long-lasting and recurrence rates are still high. Moreover, the results in persistent AF patients are far from optimal, require the creation of extensive atrial lesions and repeated procedures. The main reason that explains the current situation is the incomplete understanding of mechanisms underlying AF maintenance despite many years of research and speculation.
The incremental value of ablation of high frequency sources following circumferential PV isolation has not been assessed. There is no prospective data available as to the safety and benefit of such a combined approach in patients with paroxysmal and chronic AF. Such information would be very important in helping guide the future direction of ablative therapy for AF as well as helping to answer important questions about the role of high frequency sites in chronic AF treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Felipe Atienza, MD | 34-91-586-8281 | fatienzaf@secardiologia.es |
Spain | |
Hospital Virgen de la Salud | |
Toledo, Spain, 45004 | |
Hospital de Basurto | |
Bilbao, Spain, 48013 | |
Hospital Virgen de las Nieves | |
Granada, Spain, 18014 | |
Hospital General Universitario Gregorio Marañon | |
Madrid, Spain, 28007 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Juan Canalejo | |
A Coruña, Spain, 15006 |
Study Director: | Felipe Atienza, MD | Hospital General Universitario Gregorio Marañon |
Responsible Party: | Hospital General Universitario Gregorio Marañón ( Felipe Atienza ) |
Study ID Numbers: | CNIC-13 |
Study First Received: | May 6, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00674401 History of Changes |
Health Authority: | Spain: Ministry of Health and Consumption |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |