NCT04218604

The Ablate-by-LAW Study

Completed NA Last updated 30 August 2023

What this trial tests

NA trial testing Personalized atrial fibrillation ablation in Atrial Fibrillation in 106 participants. Completed in 20 July 2022.

Timeline

21 November 2020

Primary endpoint
20 July 2022

20 July 2022

Quick facts

Lead sponsor	Centro Medico Teknon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	21 November 2020
Primary completion	20 July 2022
Estimated completion	20 July 2022
Sites	5 locations across Italy, Germany, Spain

Drugs / interventions tested

• Personalized atrial fibrillation ablation

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Centro Medico Teknon — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. State of the Art of Artificial Intelligence in Clinical Electrophysiology in 2025: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), and the ESC Working Group on E-Cardiology.
   Svennberg E, Han JK, Caiani EG, Engelhardt S, et al · · 2025 · cited 39× · PMID 40163651 · DOI 10.1093/europace/euaf071
2. The Ablate-by-LAWT multicentre prospective study: Personalized paroxysmal atrial fibrillation ablation with ablation index adapted to local left atrial wall thickness.
   Alderete J, Fernández-Armenta J, Zucchelli G, Sommer P, et al · · 2024 · cited 7× · PMID 39009785 · DOI 10.1007/s10840-024-01871-2
3. A Novel Approach to Optimized Ventilation Strategies in Patients with Atrial Fibrillation: A Subgroup Analysis of the Ablate-by-LAWT-Study
   Briefs M, Jacobi MA, Bergmann A, Woldt MP, et al · · 2026 · DOI 10.21203/rs.3.rs-8785402/v1
4. The multicenter ablate-by-LAW study: personalized paroxysmal atrial fibrillation ablation according to the local left atrial wall thickness
   · 2024