The Ablate-by-LAW Study

NCT ID: NCT04218604

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-21
• Study Completion Date: 2022-07-20

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized AF ablation using MDCT-derived LAWT

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.

Group Type: EXPERIMENTAL

Personalized atrial fibrillation ablation

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Diabetes Center North Rhine-Westphalia

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: collaborator

Hospital Universitario Puerta del Mar

OTHER

Sponsor Role: collaborator

Centro Medico Teknon

OTHER

Sponsor Role: lead

Responsible Party

Antonio Berruezo, MD, PhD

Principal investigator, cardiologist, cardiac electrophysiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Germany; Italy; Spain

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Ablation-by-LAW

Identifier Type: -

Identifier Source: org_study_id