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The Ablate-by-LAW Study

NCT04218604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Personalized 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 & Collaborators

  • Heart and Diabetes Center North Rhine-Westphalia

    collaborator OTHER

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Hospital Universitario Puerta del Mar

    collaborator OTHER

  • Centro Medico Teknon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-21
Primary Completion
2022-07-20
Completion
2022-07-20

Countries

  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218604 on ClinicalTrials.gov