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

NCT ID: NCT04250181

Last Updated: 2020-02-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-02-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Maciej Wójcik, MD, PhD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Poland

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.

Reference Type RESULT
PMID: 22389422 (View on PubMed)

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.

Reference Type RESULT
PMID: 28038729 (View on PubMed)

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.

Reference Type RESULT
PMID: 19943098 (View on PubMed)

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.

Reference Type RESULT
PMID: 17900251 (View on PubMed)

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.

Reference Type RESULT
PMID: 30357991 (View on PubMed)

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.

Reference Type RESULT
PMID: 30712645 (View on PubMed)

Other Identifiers

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HPvSP-AF ablation

Identifier Type: -

Identifier Source: org_study_id

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