The purpose of this study is to gather data regarding the utilization of the FARAVIEW™ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects undergoing catheter-based endocardial mapping and catheter-based ablation treatment of Atrial Fibrillation.
The objective of this study is to obtain First-in-Human (FIH) experience with the FARAVIEW™ technology of the RHYTHMIA HDx™ Mapping System when it is used to visualize and track the FARAWAVE NAV™ Pulsed Field Ablation (PFA) catheter in the treatment of Atrial Fibrillation (AF). The study will collect FIH data on user experience and workflow using the FARAVIEW technology to visualize and track the FARAWAVE NAV PFA catheter (part of the FARAPULSE™ Pulsed Field Ablation System). Subjects with Paroxysmal and Persistent Atrial Fibrillation will be included in this study. NAVIGATE PF Phase 2 has the same objective of the NAVIGATE PF study and incorporates a Day 60 remapping procedure and Day 90 safety follow-up. This procedure has the additional objective to assess durability of isolation and to compare electro-anatomical maps information between Index procedure and Day 60 remapping. One clinical site in Europe that participated in NAVIGATE PF and enrolled under protocol ver A., will contribute enrollments in Phase 2 of the NAVIGATE PF study. Approximately 30 subjects will be enrolled in Phase 2 of the NAVIGATE PF study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
For subjects with paroxysmal AF, Pulmonary Vein Isolation will be performed with the FARAWAVE NAV catheter. For subjects with persistent AF, left atrial posterior wall isolation (PWI) may also be performed at the discretion of the investigator, with the FARAWAVE NAV PFA catheter.
Na Homolce Hospital
Prague, Czechia
Mater Private Hospital
Dublin, Ireland
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Number of subjects with PVI success
PVI success is defined as the proportion of veins isolated vs reconnected at the end of the procedure as assessed by a site's standard of care method for testing vein isolation
Time frame: At the end of the ablation procedure
Number of subjects with PWI success
PWI success is defined as the isolation of the left atrial PW at the end of the procedure as assessed by a site's standard of care method for testing
Time frame: At the end of the ablation procedure
Physician feedback on FARAVIEW technology of the RHYTHMIA mapping system by means of a questionnaire
Physician feedback on the FARAVIEW technology of the RHYTHMIA mapping system will be collected by means of a questionnaire.
Time frame: At the end of the ablation procedure
umber of subjects presenting with PV or PW reconnections site's standard of care method. Procedural complications: device and/or procedure-related AEs.
Device and/or procedure-related AEs will be collected to evaluate the procedural complications rate.
Time frame: At the end of the ablation procedure
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