Simplified Pulmonary Vein Isolation Using singLe Catheter and IntraCardiac Echocardiography

NCT04923009 | Unknown Phase 4

• 1 other identifier: CMKP nr 15/2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Ablation for paroxysmal atrial fibrillation (PAF) by means of pulmonary vein isolation (PVI) is the principal method for the treatment of PAF. Usually, PVI is confirmed by recording PV potentials (PVP) from the circular catheter placed at the ostium of PV. However, newer and faster methods became avialable. The only currently available technique which can visualize LA anatomy on-line, is intracardiac echocardiography (ICE). It seems that ICE could replace all other techniques used for LA imaging. Also, there may be no need for introducing diagnostic catheters and only ablation catheter and single transseptal puncture will do. Hypothesis. Simplified ICE-based ablation is faster and with shorter fluoroscopy time than standard ablation without compromising safety and efficacy and with no significant increase in costs. Aim. To compare procedural data, costs, safety and efficacy of simplified ICE-based ablation versus standard RF ablation for AF. Methods. This is prospective, controlled trial. Three centers will be included: center 1 where simplified ICE-based procedure is performed and centers 2 and 3 where standard approach is used. Patients with PAF will be allocated to two approaches: (1) standard (n=45) arm undergoing multi-electrode RF ablation in centers 2 and 3 and (2) the simple-ICE group (n=45) undergoing RF ablation in center 1 using ablation catheter and ICE catheter only. Ablation procedure will be performed using electro-anatomical system according to the CLOSE protocol. In the simple-ICE group PVI is confirmed by lack of LA capture during pacing from or up to 5 mm inside the ablation line. In the standard group both pacing from ablation line and signals from the circular diagnostic electrode will be used to confirm PVI. A one year follow-up is planned including three visits in cardiology clinics with 4-7 day Holter ECG 3, 6 and 12 months after the procedure. Assessed outcomes include duration of procedure, duration and dose of radiation, one-year procedural efficacy, peri- and post-procedural complications and cost-efficacy

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; intracardiac echocardiography

Outcome Measures

Primary Outcomes (1)

• Duration of procedure

  calculated from first skin puncture to sheaths removal

  100 - 240 minutes

Secondary Outcomes (5)

• Dose of radiation

  up to 4 hours

• Duration of radiation

  up to 20 minutes

• One-year procedural efficacy

  up to 366 days

• Peri- and post-procedural complications

  up to 28 days

• Cost-efficacy

  two years

Study Arms (2)

Simple-ICE group

EXPERIMENTAL

Patients undergoing ablation using only ICE visualization and ablation catheter

Procedure: ICE visualization and map construction

Standard mapping catheter without ICE

ACTIVE COMPARATOR

Patients undergoing ablation using standard approach including diagnostic and mapping electrodes as well as ablation electrode

Procedure: ICE visualization and map construction

Interventions

ICE visualization and map construction PROCEDURE

Radio-frequency ablation of atrial fibrillation

Also known as: RF ablation

Simple-ICE group; Standard mapping catheter without ICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• first ablation for AF
• written informed consent.

You may not qualify if:

• previous AF ablations
• anticipated need for more complex ablation than PVI only
• lack of written informed consent

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, 04-073, Poland

RECRUITING

Related Publications (13)

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  PMID: 20036199 BACKGROUND

• Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.

  PMID: 23644091 BACKGROUND

• Caponi D, Corleto A, Scaglione M, Blandino A, Biasco L, Cristoforetti Y, Cerrato N, Toso E, Morello M, Gaita F. Ablation of atrial fibrillation: does the addition of three-dimensional magnetic resonance imaging of the left atrium to electroanatomic mapping improve the clinical outcome?: a randomized comparison of Carto-Merge vs. Carto-XP three-dimensional mapping ablation in patients with paroxysmal and persistent atrial fibrillation. Europace. 2010 Aug;12(8):1098-104. doi: 10.1093/europace/euq107. Epub 2010 Apr 17.

  PMID: 20400766 BACKGROUND

• De Potter T Jr, Bardhaj G, Viggiano A, Morrice K, Geelen P. Three-dimensional Rotational Angiography as a Periprocedural Imaging Tool in Atrial Fibrillation Ablation. Arrhythm Electrophysiol Rev. 2014 Nov;3(3):173-6. doi: 10.15420/aer.2014.3.3.173. Epub 2014 Nov 29.

  PMID: 26835087 BACKGROUND

• Singh SM, Heist EK, Donaldson DM, Collins RM, Chevalier J, Mela T, Ruskin JN, Mansour MC. Image integration using intracardiac ultrasound to guide catheter ablation of atrial fibrillation. Heart Rhythm. 2008 Nov;5(11):1548-55. doi: 10.1016/j.hrthm.2008.08.027. Epub 2008 Aug 29.

  PMID: 18984531 BACKGROUND

• Rordorf R, Chieffo E, Savastano S, Vicentini A, Petracci B, De Regibus V, Valentini A, Klersy C, Dore R, Landolina M. Anatomical mapping for atrial fibrillation ablation: a head-to-head comparison of ultrasound-assisted reconstruction versus fast anatomical mapping. Pacing Clin Electrophysiol. 2015 Feb;38(2):187-95. doi: 10.1111/pace.12539. Epub 2014 Dec 2.

  PMID: 25469451 BACKGROUND

• Kaseno K, Hisazaki K, Nakamura K, Ikeda E, Hasegawa K, Aoyama D, Shiomi Y, Ikeda H, Morishita T, Ishida K, Amaya N, Uzui H, Tada H. The impact of the CartoSound(R) image directly acquired from the left atrium for integration in atrial fibrillation ablation. J Interv Card Electrophysiol. 2018 Dec;53(3):301-308. doi: 10.1007/s10840-018-0368-5. Epub 2018 Apr 14.

  PMID: 29656326 BACKGROUND

• Baran J, Stec S, Pilichowska-Paszkiet E, Zaborska B, Sikora-Frac M, Krynski T, Michalowska I, Lopatka R, Kulakowski P. Intracardiac echocardiography for detection of thrombus in the left atrial appendage: comparison with transesophageal echocardiography in patients undergoing ablation for atrial fibrillation: the Action-Ice I Study. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1074-81. doi: 10.1161/CIRCEP.113.000504. Epub 2013 Nov 15.

  PMID: 24243787 BACKGROUND

• Brooks AG, Wilson L, Chia NH, Lau DH, Alasady M, Leong DP, Laborderie J, Roberts-Thomson KC, Young GD, Kalman JM, Sanders P. Accuracy and clinical outcomes of CT image integration with Carto-Sound compared to electro-anatomical mapping for atrial fibrillation ablation: a randomized controlled study. Int J Cardiol. 2013 Oct 3;168(3):2774-82. doi: 10.1016/j.ijcard.2013.03.130. Epub 2013 Apr 25.

  PMID: 23623342 BACKGROUND

• Kulakowski P, Sikorska A, Piotrowski R, Krynski T, Baran J. Ablation for paroxysmal atrial fibrillation-real-life results from a middle-volume electrophysiology laboratory. J Interv Card Electrophysiol. 2021 Dec;62(3):549-556. doi: 10.1007/s10840-020-00937-1. Epub 2021 Jan 9.

  PMID: 33423186 BACKGROUND

• Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

  PMID: 9725923 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Piotr Kulakowski, Prof

CONTACT

+48 604455081; kulak@kkcmkp.pl

Jakub Baran, Prof

CONTACT

+ 48 22 5152757; jakub.baran1111@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Consecutive patients prospectively included in one of the two study groups

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 11, 2021
• Study Start: May 24, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from May 2024
• Access Criteria: after personal contact access criteria will be defined

Locations

PL (1)