The Ablate-by-LAW Study

NCT04218604 | Completed

• 1 other identifier: Ablation-by-LAW
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 5

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

Keywords

atrial fibrillation; catheter-based ablation; radiofrequency ablation; pulmonary vein isolation; left atrial wall thickness; multidetector cardiac tomography

Outcome Measures

Primary Outcomes (1)

• Arrhythmia-free survival

  1-year atrial arrhythmia-free survival

  1 year

Secondary Outcomes (3)

• Acute procedural outcomes

  1 day

• Peri-procedural complications

  1 month

• REDO outcomes

  2 years

Study Arms (1)

Personalized AF ablation using MDCT-derived LAWT

EXPERIMENTAL

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.

Procedure: Personalized atrial fibrillation ablation

Interventions

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)

Personalized AF ablation using MDCT-derived LAWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Indication for paroxysmal atrial fibrillation ablation.
• Signed informed consent.

You may not qualify if:

• Age \< 18 years.
• Pregnancy.
• Previous AF ablation procedure (REDO).

Sponsors & Collaborators

• Centro Medico Teknon: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• Hospital Universitario Puerta del Mar: collaborator

Study Sites (5)

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Location

Heart Center Leipzig University Hospital

Leipzig, Germany

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

Teknon Medical Center

Barcelona, 08022, Spain

Location

Puerta del Mar University Hospital

Cadiz, Spain

Location

Related Publications (29)

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• Alderete J, Fernandez-Armenta J, Zucchelli G, Sommer P, Nazarian S, Falasconi G, Soto-Iglesias D, Silva E, Mazzocchetti L, Bergau L, Khoshknab M, Penela D, Berruezo A. The Ablate-by-LAWT multicentre prospective study: Personalized paroxysmal atrial fibrillation ablation with ablation index adapted to local left atrial wall thickness. J Interv Card Electrophysiol. 2024 Dec;67(9):2089-2099. doi: 10.1007/s10840-024-01871-2. Epub 2024 Jul 15.

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, cardiologist, cardiac electrophysiologist

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 6, 2020
• Study Start: November 21, 2020
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); IT (1); ES (2)