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

Atrial Fibrillation Clinical Trial

— HPvSP-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250181
• Other study ID #: HPvSP-AF ablation
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: February 8, 2020

Study information

• Verified date: February 2020
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 8, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

References & Publications (6)

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( — View Citation

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, K — View Citation

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 — View Citation

Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castellá 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 F — View Citation

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. — View Citation

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure time:	Total procedure time (needle to needle time).	procedure
Secondary	Left atrial dwelling time	time of left atrium instrumentation	transeptal access to removal of a catheter and a sheath
Secondary	Voltage mapping time	time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium.	procedure
Secondary	Total RF time	time of all performed radiofrequency (RF) applications	procedure
Secondary	Total number of RF applications	number of all RF applications performed during a procedure	procedure
Secondary	X-Ray time	the total time of fluoroscopy	procedure
Secondary	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
Secondary	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
Secondary	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