High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients (HPvSP-AF)

HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: RF ablation of atrial fibrillation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-091
    • Medical University of Lublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

Description

Inclusion Criteria:

• symptomatic patients with non-valvular AF,
• 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:

• age below 18 or above 85 years,
• left ventricle ejection fraction<55%,
• previous procedure in left atrium,
• valvular AF

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard RF; ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall	Other: 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)	Other: 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)	Other: RF ablation of atrial fibrillation; Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time:	Total procedure time (needle to needle time).	procedure

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Principal Investigator: MACIEJ MACIEJ, MD, Medical University of Lublin, Poland

Publications and helpful links

General Publications

• 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. Erratum In: Rev Esp Cardiol (Engl Ed). 2017 Nov;70(11):1031. 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): February 8, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation ablation; high power radiofrequency ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HPvSP-AF ablation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No