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

NCT07014423 | Completed DMC

• 1 other identifier: NL-009618
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation (AF)

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

Outcome Measures

Primary Outcomes (1)

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

  Procedure Day

Secondary Outcomes (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.

  Procedure Day

Study Arms (2)

FARAVIEW group

OTHER

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

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

FARAWAVE Group

OTHER

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

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

Interventions

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

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

FARAVIEW group

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

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

FARAWAVE Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• History of prior Atrial Fibrillation ablation.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (18)

• 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.

  PMID: 36938977 BACKGROUND

• 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.

  PMID: 30874716 BACKGROUND

• 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.

  PMID: 37427302 BACKGROUND

• 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.

  PMID: 27957164 BACKGROUND

• 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.

  PMID: 27957132 BACKGROUND

• 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.

  PMID: 27909489 BACKGROUND

• 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.

  PMID: 31085321 BACKGROUND

• 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.

  PMID: 30139499 BACKGROUND

• 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.

  PMID: 38964447 BACKGROUND

• 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.

  PMID: 39169533 BACKGROUND

• 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.

  PMID: 37879163 BACKGROUND

• 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.

  PMID: 30786231 BACKGROUND

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

  PMID: 16533920 BACKGROUND

• 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.

  PMID: 31431051 BACKGROUND

• 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.

  PMID: 37913929 BACKGROUND

• 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.

  PMID: 38631724 BACKGROUND

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

  PMID: 11093410 BACKGROUND

• 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.

  PMID: 39680399 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is investigator-initiated, prospective, international, multicenter randomized controlled trial

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 11, 2025
• Study Start: September 15, 2025
• Primary Completion: December 9, 2025
• Study Completion: January 20, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-05

Locations

NL (2)