Atrial Fibrillation (AF)
Conditions
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
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.
Interventions
PROCEDUREThe Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software.
Pulmonary Vein Isolation with the additional use of the FARAVIEW mapping system (The additional mapping approach)
PROCEDUREThe Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.
Pulmonary Vein Isolation without the use of the FARAVIEW mapping system.
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is investigator-initiated, prospective, international, multicenter randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Eccentricity Index of the pulmonary veins' antral ablation lesions in both study groups. | Procedure Day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Contacts
STUDY_CHAIRYuri Blaauw, MD, PhD
University Medical Center Groningen
STUDY_DIRECTORSing-Chien Yap, MD, PhD
Erasmus Medical Center
Outcome results
None listed