The Ablate-by-LAW Study

Quirónsalud

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Personalized atrial fibrillation ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04218604

Ablation-by-LAW

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Personalized AF ablation using MDCT-derived LAWT

Experimental group

Description:

Pre-procedural MDCT images will be analysed in Teknon Medical Center (core-lab), using ADAS-3D™ (Galgo Medical, Barcelona, Spain) to obtain 3D atrial wall thickness maps that will be introduced into CARTO® navigation system (Biosense Webster, Diamond Bar, California, US). PVI will be performed point-by-point, aiming to complete a RF circle around the PV ostia (nephroid shape) on the 3D geometry using a ThermoCool® SmartTouch® 3.5-mm irrigated tip contact force-sensing RF ablation catheter (Biosense Webster, Inc.). AI targets will be defined by LAWT on the thickness color map, as follows: Thickness \< 1 mm (red): 300; 1-2 mm (yellow): 350; 2-3 mm (green): 400; 3-4 mm (blue): 450; \> 4 mm (purple): 500. The recommended power settings to reach these AI values will be, in general, 35 W for the posterior wall and 40 W for the anterior wall. Wherever local AWT is \> 3 mm (green and blue colors), an increased RF power (50 W) will be permitted.

Treatment:

Procedure: Personalized atrial fibrillation ablation