A Phase 3 interventional study of catheter ablation and catheter ablation in Atrial Fibrillation and Perimitral Flutter, sponsored by Texas Cardiac Arrhythmia Research Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-07-11.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Phase 3, Interventional, and Treatment
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 44 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Radio-frequency catheter ablation of the mitral isthmus only
Procedure: catheter ablation
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Procedure: catheter ablation
perimitral flutter ablation by blocking the mitral isthmus
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy
Time frame: 1 year
Total number of hospitalizations during the study period Change in quality of life
Time frame: 12 months
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation