AzTrials
AzTrials

Atrial Fibrillation (AF)MAP-PFANCT07014423

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

A study testing The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software. and The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software. in people with Atrial Fibrillation (AF), run by University Medical Center Groningen at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software. and The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesNetherlands
Study dates
15 Sep 2025to 20 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • -History of prior Atrial Fibrillation ablation.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • University Medical Center Groningen

    Groningen

  • Erasmus Medical Center

    Rotterdam

Other trials in Netherlands

About this study

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.

Read the detailed description

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.

Being tested
The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software., The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.
Keywords
Electroanatomical mapping, Pulsed Field Ablation, Atrial Fibrillation, The FARAPULSE system, FARAWAVE catheter, FARAVIEW mapping software, Pulmonary vein isolation, Fluoroscopy, Intracardiac Echocardiography, High density mapping, Eccentricity Index
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

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

Study groups in NCT07014423
Study groupRoleWhat they receive
FARAVIEW groupOtherThe FARAVIEW mapping software usage will be provided to this arm.
Receives: Procedure: The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software.
FARAWAVE GroupOtherThis FARAVIEW mapping software will not be used in this arm.
Receives: Procedure: The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Eccentricity Index of the pulmonary veins' antral ablation lesions in both study groups.

    Measured: Procedure Day

Secondary outcomes (1)

  1. The number of additional "touch-up" ablations needed according to the operator in both study groups after the initial ablation was concluded and post ablation map was performed.

    Measured: Procedure Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start15 Sep 2025
  3. Primary completion9 Dec 2025
  4. Study completion20 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is investigator-initiated, prospective, international, multicenter randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07014423
Sponsor's protocol ID
NL-009618
Acronym
MAP-PFA
Status last verified
May 2026
First submitted
28 May 2025
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 36938977

  • 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.

    PubMed 30874716

  • 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.

    PubMed 37427302

  • 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.

    PubMed 27957164

  • 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.

    PubMed 27957132

  • 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.

    PubMed 27909489

  • 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.

    PubMed 31085321

  • 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.

    PubMed 30139499

  • 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.

    PubMed 38964447

  • 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.

    PubMed 39169533

  • 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.

    PubMed 37879163

  • 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.

    PubMed 30786231

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

    PubMed 16533920

  • 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.

    PubMed 31431051

  • 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.

    PubMed 37913929

Questions about this trial

What is this clinical trial studying?

A study testing The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software. and The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software. in people with Atrial Fibrillation (AF), run by University Medical Center Groningen at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Eccentricity Index of the pulmonary veins' antral ablation lesions in both study groups. (time frame: Procedure Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07014423, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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