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The Ablate-by-LAW Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218604
Recruitment Status : Completed
First Posted : January 6, 2020
Last Update Posted : August 30, 2023
Sponsor:
Collaborators:
Heart and Diabetes Center North Rhine-Westphalia
Azienda Ospedaliero, Universitaria Pisana
Heart Center Leipzig - University Hospital
Hospital Universitario Puerta del Mar
Information provided by (Responsible Party):
Antonio Berruezo, MD, PhD, Centro Medico Teknon

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 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 : November 21, 2020
Actual Primary Completion Date : July 20, 2022
Actual Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Arrhythmia-free survival [ Time Frame: 1 year ]
    1-year atrial arrhythmia-free survival


Secondary Outcome Measures :
  1. Acute procedural outcomes [ Time Frame: 1 day ]
    Procedure times

  2. Peri-procedural complications [ Time Frame: 1 month ]
  3. REDO outcomes [ Time Frame: 2 years ]
    Mean LAWT at late reconnection sites


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218604


Locations
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Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Heart Center Leipzig University Hospital
Leipzig, Germany
Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Spain
Teknon Medical Center
Barcelona, Spain, 08022
Puerta del Mar University Hospital
Cadiz, Spain
Sponsors and Collaborators
Centro Medico Teknon
Heart and Diabetes Center North Rhine-Westphalia
Azienda Ospedaliero, Universitaria Pisana
Heart Center Leipzig - University Hospital
Hospital Universitario Puerta del Mar
  Study Documents (Full-Text)

Documents provided by Antonio Berruezo, MD, PhD, Centro Medico Teknon:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] June 25, 2020

More Information
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Publications of Results:

Other Publications:
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15. No abstract available.

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Responsible Party: Antonio Berruezo, MD, PhD, Principal investigator, cardiologist, cardiac electrophysiologist, Centro Medico Teknon
ClinicalTrials.gov Identifier: NCT04218604    
Other Study ID Numbers: Ablation-by-LAW
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Berruezo, MD, PhD, Centro Medico Teknon:
atrial fibrillation
catheter-based ablation
radiofrequency ablation
 pulmonary vein isolation
left atrial wall thickness
multidetector cardiac tomography
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes