High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

NCT04250181 | Completed

• 1 other identifier: HPvSP-AF ablation
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation ablation; high power radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Procedure time:

  Total procedure time (needle to needle time).

  procedure

Secondary Outcomes (8)

• Left atrial dwelling time

  transeptal access to removal of a catheter and a sheath

• Voltage mapping time

  procedure

• Total RF time

  procedure

• Total number of RF applications

  procedure

• X-Ray time

  procedure

Study Arms (3)

Standard RF

ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall

Other: RF ablation of atrial fibrillation

High RF 40W (40 Watts)

ablation with RF power of 40 watts (40W)

Other: RF ablation of atrial fibrillation

High RF 50W (50 Watts)

ablation with RF power of 50 watts (50W)

Other: RF ablation of atrial fibrillation

Interventions

RF ablation of atrial fibrillation OTHER

Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

High RF 40W (40 Watts); High RF 50W (50 Watts); Standard RF

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

You may qualify if:

• symptomatic patients with non-valvular AF,
• aged:18-85, first procedure in left atrium,
• left ventricle ejection fraction \>55%

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Medical University of Lublin

Lublin, 20-091, Poland

Location

Related Publications (6)

• 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.

  PMID: 22389422 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.

  PMID: 28038729 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.

  PMID: 19943098 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.

  PMID: 17900251 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.

  PMID: 30357991 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.

  PMID: 30712645 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MACIEJ MACIEJ, MD

  MEDICAL UNIVERSITY OF LUBLIN, POLAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: November 15, 2019
• Primary Completion: January 20, 2020
• Study Completion: February 8, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

PL (1)