The Ablate-by-LAW Study

Sponsor

Centro Medico Teknon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04218604

Collaborator

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

281

Enrollment

Locations

Arm

16.3

Anticipated Duration (Months)

56.2

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Personalized atrial fibrillation ablation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

281 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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)

Arm

Intervention/Treatment

Experimental: 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.

Procedure: 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)

Outcome Measures

Primary Outcome Measures

Arrhythmia-free survival [1 year]
1-year atrial arrhythmia-free survival

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen	Germany
2	Heart Center Leipzig University Hospital	Leipzig	Germany
3	Azienda Ospedaliero-Universitaria Pisana	Pisa	Italy
4	Teknon Medical Center	Barcelona	Spain	08022
5	Puerta del Mar University Hospital	Cadiz	Spain