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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT07014423
• Lead Sponsor: University Medical Center Groningen

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.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Eccentricity Index of the pulmonary veins' antral ablation lesions in both study groups.	Procedure Day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands