CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Personalized atrial fibrillation ablationprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04218604
NCT04218604N/ACompleted

Feasibility and Efficacy of Tailoring Ablation Index to Left Atrial Wall Thickness During Atrial Fibrillation Ablation: The Ablate By-LAW Study

Centro Medico Teknon·interventional·Posted Jan 6, 2020·Updated Aug 30, 2023

In Brief

A clinical study evaluating Personalized atrial fibrillation ablation for Atrial Fibrillation. Completed, enrolled 106 participants across 5 sites in 3 countries.

Detailed Summary

Of all the determinants of lesion creation during atrial fibrillation (AF) ablation, left atrial wall thickness (LAWT), as measured with multi-detector cardiac tomography (MDCT) is one key element that has been evaluated in some retrospective analyses but is not yet used per protocol to modulate the radiofrequency delivery. Adapting ablation index (AI) to LAWT would be very useful in standardising the ablation procedure with parameters fitted to every patient, enabling the development of a personalized approach that will both: i) increase efficacy by performing transmural lesions to prevent the formation of conduction gaps in the initial lesion set, and ii) increase safety by preventing excessive RF delivery on thin wall areas related to procedural complications, such as cardiac perforation or atrio-esophageal fistula. The investigators sought to evaluate the feasibility, safety, efficacy and reproducibility of guiding AF ablation procedures with the integrated MDCT-derived LAWT information.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 6, 2020
Enrollment StartNov 21, 2020
Primary CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.5 years ago

Interventions

Personalized atrial fibrillation ablationprocedure

Atrial fibrillation (AF) ablation adapting the ablation index (AI) target in a point-by-point manner, according the local left atrial wall thickness (LAWT), as measured by multidetector cardiac tomography (MDCT)