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OpenTrials
Completed

NCT Number: NCT04218604

The Ablate-by-LAW Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Personalized atrial fibrillation ablation

Procedure

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)

Primary outcomes

  1. Arrhythmia-free survival

    Time frame: 1 year

    1-year atrial arrhythmia-free survival

Secondary outcomes

  1. Acute procedural outcomes

    Time frame: 1 day

    Procedure times

  2. Peri-procedural complications

    Time frame: 1 month

  3. REDO outcomes

    Time frame: 2 years

    Mean LAWT at late reconnection sites

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana
  • Heart Center Leipzig - University Hospital
  • Heart and Diabetes Center North Rhine-Westphalia
  • Hospital Universitario Puerta del Mar

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2020
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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