The Ablate-by-LAW Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04218604
• Lead Sponsor: Centro Medico Teknon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2020-11-21
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Arrhythmia-free survival	1 year	1-year atrial arrhythmia-free survival

Secondary Outcome Measures

Name	Time	Method
Peri-procedural complications	1 month
Acute procedural outcomes	1 day	Procedure times
REDO outcomes	2 years	Mean LAWT at late reconnection sites

Trial Locations

Locations (5)

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Heart Center Leipzig University Hospital; 🇩🇪 Leipzig, Germany

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy

Teknon Medical Center; 🇪🇸 Barcelona, Spain

Puerta del Mar University Hospital; 🇪🇸 Cadiz, Spain