Back to resultsThe Ablate-by-LAW Study
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Personalized atrial fibrillation ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter-based ablation, radiofrequency ablation, pulmonary vein isolation, left atrial wall thickness, multidetector cardiac tomography
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).
Sites / Locations
- Herz- und Diabeteszentrum Nordrhein-Westfalen
- Heart Center Leipzig University Hospital
- Azienda Ospedaliero-Universitaria Pisana
- Teknon Medical Center
- Puerta del Mar University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalized AF ablation using MDCT-derived LAWT
Arm 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.
Outcomes
Primary Outcome Measures
Arrhythmia-free survival
1-year atrial arrhythmia-free survival
Secondary Outcome Measures
Acute procedural outcomes
Procedure times
Peri-procedural complications
REDO outcomes
Mean LAWT at late reconnection sites
Full Information
NCT ID
NCT04218604
First Posted
December 26, 2019
Last Updated
August 29, 2023
Sponsor
Centro Medico Teknon
Collaborators
Heart and Diabetes Center North Rhine-Westphalia, Azienda Ospedaliero, Universitaria Pisana, Heart Center Leipzig - University Hospital, Hospital Universitario Puerta del Mar
1. Study Identification
Unique Protocol Identification Number
NCT04218604
Brief Title
The Ablate-by-LAW Study
Official Title
Feasibility and Efficacy of Tailoring Ablation Index to Left Atrial Wall Thickness During Atrial Fibrillation Ablation: The Ablate By-LAW Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2020 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Teknon
Collaborators
Heart and Diabetes Center North Rhine-Westphalia, Azienda Ospedaliero, Universitaria Pisana, Heart Center Leipzig - University Hospital, Hospital Universitario Puerta del Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter-based ablation, radiofrequency ablation, pulmonary vein isolation, left atrial wall thickness, multidetector cardiac tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized AF ablation using MDCT-derived LAWT
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Personalized atrial fibrillation ablation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Arrhythmia-free survival
Description
1-year atrial arrhythmia-free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acute procedural outcomes
Description
Procedure times
Time Frame
1 day
Title
Peri-procedural complications
Time Frame
1 month
Title
REDO outcomes
Description
Mean LAWT at late reconnection sites
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen
City
Bad Oeynhausen
Country
Germany
Facility Name
Heart Center Leipzig University Hospital
City
Leipzig
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Facility Name
Teknon Medical Center
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Puerta del Mar University Hospital
City
Cadiz
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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The Ablate-by-LAW Study
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