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Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes - NCT01173796-(Clinical Trial 713108)



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City:  Austin
State:  
TX
Zip Code:
Conditions: Atrial Fibrillation - Perimitral Flutter
Purpose: This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.
Study summary: Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation. This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers. Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.
Criteria: Inclusion Criteria: - Patients with previous AF ablation presenting with PMFL and recurrent AF Age: 18- 75 years Willingness and ability to give written informed consent Therapeutic INR for at least 4 weeks prior to the procedure Exclusion Criteria: - Reversible causes of AF such as pericarditis and hyperthyroidism Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation Enrollment in another clinical study Any other terminal illness
Study is available at: Texas Cardiac Arrhythmia Research Foundation
Austin, TX
United States

Primary Contact:
Andrea Natale, MD, FACC,FHRS
Email: Andrea.Natale@stdavids.com

Secondary Contact:
Luigi Di Biase, MD
Email: dibbia@gmail.com
Phone: 512-423-9855
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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