High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients
NCT ID: NCT04250181
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2019-11-15
2020-02-08
Brief Summary
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Detailed Description
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High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.
We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Standard RF
ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall
RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
High RF 40W (40 Watts)
ablation with RF power of 40 watts (40W)
RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
High RF 50W (50 Watts)
ablation with RF power of 50 watts (50W)
RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
Interventions
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RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
* aged:18-85, first procedure in left atrium,
* exclusion of thrombus in left atrium and left atrium appendage,
* left ventricle ejection fraction \>55%
Exclusion Criteria
* left ventricle ejection fraction\<55%,
* previous procedure in left atrium,
* valvular AF
18 Years
85 Years
ALL
No
Sponsors
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Medical University of Lublin
OTHER
Responsible Party
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Maciej Wójcik, MD, PhD
Clinical Professor
Principal Investigators
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MACIEJ MACIEJ, MD
Role: PRINCIPAL_INVESTIGATOR
MEDICAL UNIVERSITY OF LUBLIN, POLAND
Locations
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Medical University of Lublin
Lublin, , Poland
Countries
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References
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Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.
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.
Galeazzi M, Ficili S, Dottori S, Elian MA, Pasceri V, Venditti F, Russo M, Lavalle C, Pandozi A, Pandozi C, Santini M. Pain perception during esophageal warming due to radiofrequency catheter ablation in the left atrium. J Interv Card Electrophysiol. 2010 Mar;27(2):109-15. doi: 10.1007/s10840-009-9447-y. Epub 2009 Nov 27.
Aryana A, Heist EK, D'Avila A, Holmvang G, Chevalier J, Ruskin JN, Mansour MC. Pain and anatomical locations of radiofrequency ablation as predictors of esophageal temperature rise during pulmonary vein isolation. J Cardiovasc Electrophysiol. 2008 Jan;19(1):32-8. doi: 10.1111/j.1540-8167.2007.00975.x. Epub 2007 Sep 24.
Patel PJ, Padanilam BJ. High-power short-duration ablation: Better, safer, and faster? J Cardiovasc Electrophysiol. 2018 Nov;29(11):1576-1577. doi: 10.1111/jce.13749. Epub 2018 Oct 25. No abstract available.
Winkle RA, Mohanty S, Patrawala RA, Mead RH, Kong MH, Engel G, Salcedo J, Trivedi CG, Gianni C, Jais P, Natale A, Day JD. Low complication rates using high power (45-50 W) for short duration for atrial fibrillation ablations. Heart Rhythm. 2019 Feb;16(2):165-169. doi: 10.1016/j.hrthm.2018.11.031.
Other Identifiers
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HPvSP-AF ablation
Identifier Type: -
Identifier Source: org_study_id
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