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Completed

NCT Number: NCT07014423

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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.

Primary outcomes

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

    Time frame: 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.

    Time frame: Procedure Day

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: MAP-PFA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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