The Added Value of Three-dimensional Electroanatomic Mapping For Accurate Delivery Of Pulsed Field Ablation In The Pulmonary Veins Compared To Pulsed Field Ablation With Fluoroscopy And/Or Intracardiac Echocardiography Alone In The Treatment Of Atrial Fibrillation: MAP-PFA Study

NCT ID: NCT07014423

Last Updated: 2026-01-23

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

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-01-20

Brief Summary

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This is a randomized control trial that aims to evaluate the added value of electro-anatomical mapping to improve the quality of pulse field ablation lesions during Atrial fibrillation ablation.

Detailed Description

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This is a multi-center randomized control trial, aims to compare the symmetry and centricity of pulmonary veins antral ablation lesions during positioning the ablation catheter with versus without the use of the FARAVIEW mapping system. The trial will enroll patients with atrial fibrillation, who are planned to undergo atrial fibrillation pulsed field ablation ablation using FARAWAVE catheter (the standard ablation catheter without FARAVIEW mapping software utilization) and FARAVIEW catheter (the upgraded catheter with features to utilize the FARVIEW mapping software) during the period of 2025. A total of 32 patients will be randomized in 1:1 ratio to either group of the trial. The aim is to enroll 16 patients from each participating institution (i.e. UMCG and Erasmus UMC). All study candidates will be either assigned to FARAVIEW (Group 1) or FARAWAVE (Group 2). Both groups will undergo post ablation high density intracardiac mapping (e.g. voltage mapping) with the ORION mapping catheter, to assess the symmetry and centrality of the antral pulmonary veins' ablation lesions in relation to the pulmonary vein ostia. We propose an Eccentricity Index to compare and reflect the central location of the pulmonary veins' antral ablation lesions' margins relative to the pulmonary veins' ostia between the two groups.

Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is investigator-initiated, prospective, international, multicenter randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FARAVIEW group

The FARAVIEW mapping software usage will be provided to this arm.

Group Type OTHER

The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software.

Intervention Type PROCEDURE

Pulmonary Vein Isolation with the additional use of the FARAVIEW mapping system (The additional mapping approach)

FARAWAVE Group

This FARAVIEW mapping software will not be used in this arm.

Group Type OTHER

The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.

Intervention Type PROCEDURE

Pulmonary Vein Isolation without the use of the FARAVIEW mapping system.

Interventions

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The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software.

Pulmonary Vein Isolation with the additional use of the FARAVIEW mapping system (The additional mapping approach)

Intervention Type PROCEDURE

The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.

Pulmonary Vein Isolation without the use of the FARAVIEW mapping system.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Atrial Fibrillation.
* Planned for ablation with Pulsed Field ablation technology.
* Able to consent for participation.

Exclusion Criteria

-History of prior Atrial Fibrillation ablation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Roger A, Cottin Y, Bentounes SA, Bisson A, Bodin A, Herbert J, Maille B, Zeller M, Deharo JC, Lip GYH, Fauchier L. Incidence of clinical atrial fibrillation and related complications using a screening algorithm at a nationwide level. Europace. 2023 May 19;25(5):euad063. doi: 10.1093/europace/euad063.

Reference Type BACKGROUND
PMID: 36938977 (View on PubMed)

Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.

Reference Type BACKGROUND
PMID: 30874716 (View on PubMed)

Schaack D, Schmidt B, Tohoku S, Bordignon S, Urbanek L, Ebrahimi R, Hirokami J, Efe TH, Chen S, Chun KJ. Pulsed Field Ablation for Atrial Fibrillation. Arrhythm Electrophysiol Rev. 2023 Apr 14;12:e11. doi: 10.15420/aer.2022.45. eCollection 2023.

Reference Type BACKGROUND
PMID: 37427302 (View on PubMed)

Kuwahara T. Intracardiac Echocardiography in Catheter Ablation for Atrial Fibrillation: It Is Better to See What You Are Doing? J Atr Fibrillation. 2015 Apr 30;7(6):1215. doi: 10.4022/jafib.1215. eCollection 2015 Apr-May.

Reference Type BACKGROUND
PMID: 27957164 (View on PubMed)

Rolf S, Hindricks G, Sommer P, Richter S, Arya A, Bollmann A, Kosiuk J, Koutalas E. Electroanatomical mapping of atrial fibrillation: Review of the current techniques and advances. J Atr Fibrillation. 2014 Dec 31;7(4):1140. doi: 10.4022/jafib.1140. eCollection 2014 Dec.

Reference Type BACKGROUND
PMID: 27957132 (View on PubMed)

Nedios S, Sommer P, Bollmann A, Hindricks G. Advanced Mapping Systems To Guide Atrial Fibrillation Ablation: Electrical Information That Matters. J Atr Fibrillation. 2016 Apr 30;8(6):1337. doi: 10.4022/jafib.1337. eCollection 2016 Apr-May.

Reference Type BACKGROUND
PMID: 27909489 (View on PubMed)

Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

Reference Type BACKGROUND
PMID: 31085321 (View on PubMed)

Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, Funosako M, Mannuva BB, Sediva L, Neuzil P. Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin Electrophysiol. 2018 Aug;4(8):987-995. doi: 10.1016/j.jacep.2018.04.005. Epub 2018 May 11.

Reference Type BACKGROUND
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Badertscher P, Knecht S, Rosso R, Krisai P, Spreen D, Katic J, Du Fay de Lavallaz J, Sticherling C, Kuhne M. How to perform pulmonary vein isolation using a pentaspline pulsed field ablation system for treatment of atrial fibrillation. Heart Rhythm. 2025 Jan;22(1):69-79. doi: 10.1016/j.hrthm.2024.06.058. Epub 2024 Jul 2. No abstract available.

Reference Type BACKGROUND
PMID: 38964447 (View on PubMed)

Goto K, Miyazaki S, Negishi M, Ikenouchi T, Yamamoto T, Kawamura I, Nishimura T, Takamiya T, Tao S, Takigawa M, Sasano T. Distribution of antral lesions with the novel size-adjustable cryoballoon for pulmonary vein isolation and the differences based on left atrial remodeling. J Cardiovasc Electrophysiol. 2024 Nov;35(11):2099-2108. doi: 10.1111/jce.16415. Epub 2024 Aug 21.

Reference Type BACKGROUND
PMID: 39169533 (View on PubMed)

Rems L, Rainot A, Wiczew D, Szulc N, Tarek M. Cellular excitability and ns-pulsed electric fields: Potential involvement of lipid oxidation in the action potential activation. Bioelectrochemistry. 2024 Feb;155:108588. doi: 10.1016/j.bioelechem.2023.108588. Epub 2023 Oct 12.

Reference Type BACKGROUND
PMID: 37879163 (View on PubMed)

Kotnik T, Rems L, Tarek M, Miklavcic D. Membrane Electroporation and Electropermeabilization: Mechanisms and Models. Annu Rev Biophys. 2019 May 6;48:63-91. doi: 10.1146/annurev-biophys-052118-115451. Epub 2019 Feb 20.

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Lee RC. Cell injury by electric forces. Ann N Y Acad Sci. 2005 Dec;1066:85-91. doi: 10.1196/annals.1363.007.

Reference Type BACKGROUND
PMID: 16533920 (View on PubMed)

Asad ZUA, Yousif A, Khan MS, Al-Khatib SM, Stavrakis S. Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007414. doi: 10.1161/CIRCEP.119.007414. Epub 2019 Aug 21.

Reference Type BACKGROUND
PMID: 31431051 (View on PubMed)

Elsheikh S, Hill A, Irving G, Lip GYH, Abdul-Rahim AH. Atrial fibrillation and stroke: State-of-the-art and future directions. Curr Probl Cardiol. 2024 Jan;49(1 Pt C):102181. doi: 10.1016/j.cpcardiol.2023.102181. Epub 2023 Oct 31.

Reference Type BACKGROUND
PMID: 37913929 (View on PubMed)

Wu J, Nadarajah R. The growing burden of atrial fibrillation and its consequences. BMJ. 2024 Apr 17;385:q826. doi: 10.1136/bmj.q826. No abstract available.

Reference Type BACKGROUND
PMID: 38631724 (View on PubMed)

Wyndham CR. Atrial fibrillation: the most common arrhythmia. Tex Heart Inst J. 2000;27(3):257-67.

Reference Type BACKGROUND
PMID: 11093410 (View on PubMed)

Ko D, Chung MK, Evans PT, Benjamin EJ, Helm RH. Atrial Fibrillation: A Review. JAMA. 2025 Jan 28;333(4):329-342. doi: 10.1001/jama.2024.22451.

Reference Type BACKGROUND
PMID: 39680399 (View on PubMed)

Other Identifiers

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NL-009618

Identifier Type: -

Identifier Source: org_study_id

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