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

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Atrial Fibrillation (AF)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07014423

NL-009618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

FARAVIEW group

Other group

Description:

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

Treatment:

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

FARAWAVE Group

Other group

Description:

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

Treatment:

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