Atrial Fibrillation Clinical Trial
Official title:
Feasibility and Efficacy of Tailoring Ablation Index to Left Atrial Wall Thickness During Atrial Fibrillation Ablation: The Ablate By-LAW Study
Verified date | August 2023 |
Source | Centro Medico Teknon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | July 20, 2022 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Germany | Herz- und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | |
Germany | Heart Center Leipzig University Hospital | Leipzig | |
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | |
Spain | Teknon Medical Center | Barcelona | |
Spain | Puerta del Mar University Hospital | Cadiz |
Lead Sponsor | Collaborator |
---|---|
Centro Medico Teknon | Azienda Ospedaliero, Universitaria Pisana, Heart and Diabetes Center North Rhine-Westphalia, Heart Center Leipzig - University Hospital, Hospital Universitario Puerta del Mar |
Germany, Italy, Spain,
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. — View 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. — View 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. — View 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. — View 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. — View 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 a — View 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. — View 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 techniq — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. Erratum In: Rev Esp Cardiol (Engl Ed). 2017 Nov;70(11):1031. English, Spanish. — View 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. — View 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. — View 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. — View 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. — View 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-eff — View 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. — View 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. — View 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. — View 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: — View 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. — View 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. — View 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 Fibrilla — View 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. — View 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. — View Citation
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arrhythmia-free survival | 1-year atrial arrhythmia-free survival | 1 year | |
Secondary | Acute procedural outcomes | Procedure times | 1 day | |
Secondary | Peri-procedural complications | 1 month | ||
Secondary | REDO outcomes | Mean LAWT at late reconnection sites | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |