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UnknownNCT05842499

Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia

Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
128 (estimated)
Sponsor
Hospital Universitario 12 de Octubre · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELine Set StrategySubstrate-guided ablation procedure of atypical atrial flutter
PROCEDUREConventional strategyElectrical activation-guided ablation

Timeline

Start date
2021-06-15
Primary completion
2026-01-01
Completion
2026-01-01
First posted
2023-05-06
Last updated
2023-07-11

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05842499. Inclusion in this directory is not an endorsement.