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Atrial FibrillationNCT04218604

The Ablate-by-LAW Study

A study testing Personalized atrial fibrillation ablation in people with Atrial Fibrillation, run by Centro Medico Teknon at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Personalized atrial fibrillation ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
5 sitesin 3 countries
Study dates
21 Nov 2020to 20 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Germany2 sites

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen

  • Heart Center Leipzig University Hospital

    Leipzig

Other trials in Germany

Spain2 sites

  • Teknon Medical Center

    Barcelona, 08022

  • Puerta del Mar University Hospital

    Cadiz

Other trials in Spain

Italy1 site

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa

Other trials in Italy

About this study

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

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.

Being tested
Personalized atrial fibrillation ablation
Keywords
atrial fibrillation, catheter-based ablation, radiofrequency ablation, pulmonary vein isolation, left atrial wall thickness, multidetector cardiac tomography
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized atrial fibrillation ablationProcedure or surgery

    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)

Study groups in NCT04218604
Study groupRoleWhat they receive
Personalized AF ablation using MDCT-derived LAWTExperimentalPre-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.
Receives: Procedure: Personalized atrial fibrillation ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arrhythmia-free survival

    1-year atrial arrhythmia-free survival

    Measured: 1 year

Secondary outcomes (3)

  1. Acute procedural outcomes

    Procedure times

    Measured: 1 day

  2. Peri-procedural complications

    Measured: 1 month

  3. REDO outcomes

    Mean LAWT at late reconnection sites

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2020
  2. Study start21 Nov 2020
  3. Primary completion20 Jul 2022
  4. Study completion20 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04218604
Sponsor's protocol ID
Ablation-by-LAW
Status last verified
Aug 2023
First submitted
26 Dec 2019
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

    PubMed 28038729

  • 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.

    PubMed 29021841

  • Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Kokturk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010 Dec 7;122(23):2368-77. doi: 10.1161/CIRCULATIONAHA.110.946806. Epub 2010 Nov 22.

    PubMed 21098450

  • Cappato R, Negroni S, Pecora D, Bentivegna S, Lupo PP, Carolei A, Esposito C, Furlanello F, De Ambroggi L. Prospective assessment of late conduction recurrence across radiofrequency lesions producing electrical disconnection at the pulmonary vein ostium in patients with atrial fibrillation. Circulation. 2003 Sep 30;108(13):1599-604. doi: 10.1161/01.CIR.0000091081.19465.F1. Epub 2003 Sep 8.

    PubMed 12963643

  • Kuck KH, Hoffmann BA, Ernst S, Wegscheider K, Treszl A, Metzner A, Eckardt L, Lewalter T, Breithardt G, Willems S; Gap-AF-AFNET 1 Investigators*. Impact of Complete Versus Incomplete Circumferential Lines Around the Pulmonary Veins During Catheter Ablation of Paroxysmal Atrial Fibrillation: Results From the Gap-Atrial Fibrillation-German Atrial Fibrillation Competence Network 1 Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003337. doi: 10.1161/CIRCEP.115.003337.

    PubMed 26763226

  • Ikeda A, Nakagawa H, Lambert H, Shah DC, Fonck E, Yulzari A, Sharma T, Pitha JV, Lazzara R, Jackman WM. Relationship between catheter contact force and radiofrequency lesion size and incidence of steam pop in the beating canine heart: electrogram amplitude, impedance, and electrode temperature are poor predictors of electrode-tissue contact force and lesion size. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1174-80. doi: 10.1161/CIRCEP.113.001094. Epub 2014 Nov 7.

    PubMed 25381331

  • Thiagalingam A, D'Avila A, Foley L, Guerrero JL, Lambert H, Leo G, Ruskin JN, Reddy VY. Importance of catheter contact force during irrigated radiofrequency ablation: evaluation in a porcine ex vivo model using a force-sensing catheter. J Cardiovasc Electrophysiol. 2010 Jul;21(7):806-11. doi: 10.1111/j.1540-8167.2009.01693.x. Epub 2010 Feb 1.

    PubMed 20132400

  • Barkagan M, Rottmann M, Leshem E, Shen C, Buxton AE, Anter E. Effect of Baseline Impedance on Ablation Lesion Dimensions: A Multimodality Concept Validation From Physics to Clinical Experience. Circ Arrhythm Electrophysiol. 2018 Oct;11(10):e006690. doi: 10.1161/CIRCEP.118.006690.

    PubMed 30354405

  • Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.

    PubMed 26260733

  • Shah DC, Lambert H, Nakagawa H, Langenkamp A, Aeby N, Leo G. Area under the real-time contact force curve (force-time integral) predicts radiofrequency lesion size in an in vitro contractile model. J Cardiovasc Electrophysiol. 2010 Sep;21(9):1038-43. doi: 10.1111/j.1540-8167.2010.01750.x.

    PubMed 20367658

  • De Potter T, Van Herendael H, Balasubramaniam R, Wright M, Agarwal SC, Sanders P, Khaykin Y, Latcu DG, Maury P, Pani A, Hayes J, Kalman J, Nery P, Duncan E. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018 Nov 1;20(FI_3):f410-f418. doi: 10.1093/europace/eux290.

    PubMed 29315382

  • Ho SY, Cabrera JA, Tran VH, Farre J, Anderson RH, Sanchez-Quintana D. Architecture of the pulmonary veins: relevance to radiofrequency ablation. Heart. 2001 Sep;86(3):265-70. doi: 10.1136/heart.86.3.265.

    PubMed 11514476

  • Ho SY, Sanchez-Quintana D. The importance of atrial structure and fibers. Clin Anat. 2009 Jan;22(1):52-63. doi: 10.1002/ca.20634.

    PubMed 18470938

  • Kistler PM, Ho SY, Rajappan K, Morper M, Harris S, Abrams D, Sporton SC, Schilling RJ. Electrophysiologic and anatomic characterization of sites resistant to electrical isolation during circumferential pulmonary vein ablation for atrial fibrillation: a prospective study. J Cardiovasc Electrophysiol. 2007 Dec;18(12):1282-8. doi: 10.1111/j.1540-8167.2007.00981.x. Epub 2007 Oct 3.

    PubMed 17916142

  • Takahashi K, Okumura Y, Watanabe I, Nagashima K, Sonoda K, Sasaki N, Kogawa R, Iso K, Ohkubo K, Nakai T, Hirayama A. Relation Between Left Atrial Wall Thickness in Patients with Atrial Fibrillation and Intracardiac Electrogram Characteristics and ATP-Provoked Dormant Pulmonary Vein Conduction. J Cardiovasc Electrophysiol. 2015 Jun;26(6):597-605. doi: 10.1111/jce.12660. Epub 2015 May 1.

    PubMed 25777254

Questions about this trial

What is this clinical trial studying?

A study testing Personalized atrial fibrillation ablation in people with Atrial Fibrillation, run by Centro Medico Teknon at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arrhythmia-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218604, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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