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The Ablate-by-LAW Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04218604
Enrollment
106
Registered
2020-01-06
Start date
2020-11-21
Completion date
2022-07-20
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter-based ablation, radiofrequency ablation, pulmonary vein isolation, left atrial wall thickness, multidetector cardiac tomography

Brief 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.

Interventions

PROCEDUREPersonalized atrial fibrillation ablation

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)

Sponsors

Heart and Diabetes Center North Rhine-Westphalia
CollaboratorOTHER
Azienda Ospedaliero, Universitaria Pisana
CollaboratorOTHER
Heart Center Leipzig - University Hospital
CollaboratorOTHER
Hospital Universitario Puerta del Mar
CollaboratorOTHER
Centro Medico Teknon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years. * Indication for paroxysmal atrial fibrillation ablation. * Signed informed consent.

Exclusion criteria

* Age \< 18 years. * Pregnancy. * Previous AF ablation procedure (REDO).

Design outcomes

Primary

MeasureTime frameDescription
Arrhythmia-free survival1 year1-year atrial arrhythmia-free survival

Secondary

MeasureTime frameDescription
Acute procedural outcomes1 dayProcedure times
Peri-procedural complications1 month
REDO outcomes2 yearsMean LAWT at late reconnection sites

Countries

Germany, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026