SLICE-LAMRT is a multicenter, prospective, randomized, double-blind trial that will be carried out in patients older than 18 years with atypical flutter suspected to be of left atrial origin. The aim of this trial is to evaluate the safety and superiority of a substrate-guided ablation procedure vs the conventional strategy guided by electrical activity. The composite primary endpoint is time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation.
Left atrial macroreentrant tachycardias (LAMRT), also known as left atrial flutter, represent a small percentage of supraventricular arrhythmiass. These tachycardias occur due to reentrant circuits, that is, electrical activation that occurs around natural anatomical obstacles or scar areas. Classically, by analogy with ventricular tachycardias, these tachycardias are approached by delimiting the circuit (locating the anatomical and functional obstacles), searching for critical areas for their maintenance (isthmuses, generally of slow conduction) and creating controlled lesions that interrupt these circuits (catheter ablation). This requires electromagnetic mapping systems and uses programmed stimulation techniques. This approach treats flutter(s) present at the time of ablation to prevent recurrence. However, it is not uncommon for these patients to develop new macroreentrant circuits during the subsequent clinical course, so the recurrence rate of atrial arrhythmias in this population is relatively high. The goal of this trial is to determine whether substrate-guided ablation of atypical atrial flutter is superior to electrical activation-guided ablation in reducing the recurrence of atrial arrhythmias and increasing the time to first recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia. The investigators hypothesize that ablation not only of inducible tachycardias during the ablation procedure, but guided by the substrate that is most often key to the maintenance of these tachycardias, is superior to conventional treatment in reducing associated clinical events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Substrate-guided ablation procedure of atypical atrial flutter
Electrical activation-guided ablation
Hospital Universitario 12 de Octubre
Madrid, Spain
RECRUITINGComposite primary endpoint
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation
Time frame: 18 months
Major complications
Death, stroke/systemic embolism, tamponade, during the procedure and immediate post-procedure.
Time frame: First month
Proportion of patients without recurrence of atrial arrhythmia at 18 months
Maintainance of sinus rhythm by ablation, without requiring electrical cardioversion.
Time frame: 18 months
Procedure duration
Procedure duration, radiofrequency time, left atrial time (from transseptal puncture to left atrial catheter removal), fluoroscopy time.
Time frame: In the procedure
Unplanned cardiovascular hospitalisation
Unplanned cardiovascular hospitalisation
Time frame: 18 months
Unplanned hospitalization for any cause.
Unplanned hospitalization for any cause.
Time frame: 18 months
All-cause mortality
Mortality due to any cause
Time frame: 18 months
Cardiovascular mortality
Mortality due to cardiovascular causes
Time frame: 18 months
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DOUBLE
Enrollment
128