Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.
Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard RF | ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall |
| |
| High RF 40W (40 Watts) | ablation with RF power of 40 watts (40W) |
| |
| High RF 50W (50 Watts) | ablation with RF power of 50 watts (50W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation of atrial fibrillation | Other | Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time: | Total procedure time (needle to needle time). | procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Left atrial dwelling time | time of left atrium instrumentation | transeptal access to removal of a catheter and a sheath |
| Voltage mapping time | time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with atrial fibrillation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MACIEJ MACIEJ, MD | MEDICAL UNIVERSITY OF LUBLIN, POLAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Lublin | Lublin | 20-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22389422 | Result | 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. | |
| 28038729 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| procedure |
| Total RF time | time of all performed radiofrequency (RF) applications | procedure |
| Total number of RF applications | number of all RF applications performed during a procedure | procedure |
| X-Ray time | the total time of fluoroscopy | procedure |
| Complications | both procedure-related complications and all complications in 12 moths follow-up as follows: Cardiac tamponade/perforation [yes/no], Stroke/TIA (Transient ischemic attack) [yes/no], Oesophageal injury (perforation/fistula) [yes/no], Death (procedural related, one year follow up) [yes/no], Stem pops [yes/no], Catheter char [yes/no], Phrenic nerve paralysis [yes/no], PV stenosis requiring intervention [yes/no], Gastrointestinal bleeding or gastrointestinal complaints [yes/no], Need for periprocedural pacemaker implantation [yes/no], Vascular access complication which required intervention [yes/no], Vascular access complication which not required intervention [yes/no], | 12 months |
| Number of stopped RF applications as a result of pain complained by a patient | the surrogate for assessment of the painfulness of the procedure | procedure |
| Follow-up-30s | absence any arrhythmia recurrence (AR) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL) lasting longer than 30 second | procedure |
| Result |
| 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. |
| 19943098 | Result | 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. |
| 17900251 | Result | 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. |
| 30357991 | Result | 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. |
| 30712645 | Result | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |