Clinical trial NCT04218604: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter-based ablation
radiofrequency ablation
pulmonary vein isolation
left atrial wall thickness
multidetector cardiac tomography
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
name: Azienda Ospedaliero, Universitaria Pisana
name: Heart Center Leipzig - University Hospital
name: Hospital Universitario Puerta del Mar
First posted: 2020-01-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Arrhythmia-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Acute procedural outcomes
timeFrame: 1 day
measure: Peri-procedural complications
timeFrame: 1 month
measure: REDO outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Heart Center Leipzig University Hospital
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Barcelona
country: Spain
facility: Teknon Medical Center
city: Cadiz
country: Spain
facility: Puerta del Mar University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Suenari K, Nakano Y, Hirai Y, Ogi H, Oda N, Makita Y, Ueda S, Kajihara K, Tokuyama T, Motoda C, Fujiwara M, Chayama K, Kihara Y. Left atrial thickness under the catheter ablation lines in patients with paroxysmal atrial fibrillation: insights from 64-slice multidetector computed tomography. Heart Vessels. 2013 May;28(3):360-8. doi: 10.1007/s00380-012-0253-6. Epub 2012 Apr 22.
citation: Nakamura K, Funabashi N, Uehara M, Ueda M, Murayama T, Takaoka H, Komuro I. Left atrial wall thickness in paroxysmal atrial fibrillation by multislice-CT is initial marker of structural remodeling and predictor of transition from paroxysmal to chronic form. Int J Cardiol. 2011 Apr 14;148(2):139-47. doi: 10.1016/j.ijcard.2009.10.032. Epub 2009 Nov 10.
citation: Chikata A, Kato T, Sakagami S, Kato C, Saeki T, Kawai K, Takashima S, Murai H, Usui S, Furusho H, Kaneko S, Takamura M. Optimal Force-Time Integral for Pulmonary Vein Isolation According to Anatomical Wall Thickness Under the Ablation Line. J Am Heart Assoc. 2016 Mar 15;5(3):e003155. doi: 10.1161/JAHA.115.003155.
citation: Sun JY, Yun CH, Mok GSP, Liu YH, Hung CL, Wu TH, Alaiti MA, Eck BL, Fares A, Bezerra HG. Left Atrium Wall-mapping Application for Wall Thickness Visualisation. Sci Rep. 2018 Mar 8;8(1):4169. doi: 10.1038/s41598-018-22089-z.
citation: Bishop M, Rajani R, Plank G, Gaddum N, Carr-White G, Wright M, O'Neill M, Niederer S. Three-dimensional atrial wall thickness maps to inform catheter ablation procedures for atrial fibrillation. Europace. 2016 Mar;18(3):376-83. doi: 10.1093/europace/euv073. Epub 2015 Apr 4.
citation: Schaeffer B, Willems S, Sultan A, Hoffmann BA, Luker J, Schreiber D, Akbulak R, Moser J, Kuklik P, Steven D. Loss of Pace Capture on the Ablation Line During Pulmonary Vein Isolation versus "Dormant Conduction": Is Adenosine Expendable? J Cardiovasc Electrophysiol. 2015 Oct;26(10):1075-80. doi: 10.1111/jce.12759. Epub 2015 Aug 29.
citation: Das M, Loveday JJ, Wynn GJ, Gomes S, Saeed Y, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017 May 1;19(5):775-783. doi: 10.1093/europace/euw105.
citation: Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N, Morgan M, Ronayne C, Shaw M, Snowdon R, Gupta D. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Sep;28(9):1037-1047. doi: 10.1111/jce.13281. Epub 2017 Jul 26.
citation: Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.
citation: Inoue J, Skanes AC, Gula LJ, Drangova M. Effect of Left Atrial Wall Thickness on Radiofrequency Ablation Success. J Cardiovasc Electrophysiol. 2016 Nov;27(11):1298-1303. doi: 10.1111/jce.13065. Epub 2016 Sep 16.
citation: Pambrun T, Combes S, Sousa P, Bloa ML, El Bouazzaoui R, Grand-Larrieu D, Thompson N, Martin R, Combes N, Boveda S, Haissaguerre M, Albenque JP. Contact-force guided single-catheter approach for pulmonary vein isolation: Feasibility, outcomes, and cost-effectiveness. Heart Rhythm. 2017 Mar;14(3):331-338. doi: 10.1016/j.hrthm.2016.12.008. Epub 2016 Dec 7.
citation: Steven D, Reddy VY, Inada K, Roberts-Thomson KC, Seiler J, Stevenson WG, Michaud GF. Loss of pace capture on the ablation line: a new marker for complete radiofrequency lesions to achieve pulmonary vein isolation. Heart Rhythm. 2010 Mar;7(3):323-30. doi: 10.1016/j.hrthm.2009.11.011. Epub 2009 Nov 12.
citation: Eitel C, Hindricks G, Sommer P, Gaspar T, Kircher S, Wetzel U, Dagres N, Esato M, Bollmann A, Husser D, Hilbert S, Zaker-Shahrak R, Arya A, Piorkowski C. Circumferential pulmonary vein isolation and linear left atrial ablation as a single-catheter technique to achieve bidirectional conduction block: the pace-and-ablate approach. Heart Rhythm. 2010;7(2):157-64. doi: 10.1016/j.hrthm.2009.10.003. Epub 2009 Oct 12.