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Feasibility Study on the FARAVIEW Technology | Clinical Trials | Clareo Health

COMPLETEDNA

Feasibility Study on the FARAVIEW Technology

A Study Evaluating the User Experience With the FARAVIEW™ Technology of the RHYTHMIA HDx™ Mapping System When Used With the FARAWAVE NAV™ Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation

NCT06175234•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: ≥ 18 years of age, or older if required by local law
•2. Symptomatic, documented, drug-resistant, Atrial Fibrillation
•1. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND within 180 days of the Enrollment Date one (1) ECG from any regulatory cleared rhythm monitoring device showing AF
•2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I, II, III or IV) 1
•3. Informed consent: willing and capable of providing informed consent
•4. Full participation: willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria

•1. Atrial exclusions - Any of the following atrial conditions:
•1. Prior atrial ablation: any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia other than ablation for right sided SVT or cavotricuspid isthmus ablation
•2. Atrial myxoma: current atrial myxoma
•3. Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
•4. Atrial thrombus: current left atrial thrombus
•5. Long standing persistent AF: continuous AF lasting longer than 12 months
•2. Cardiovascular exclusions - Any of the following CV conditions:
•1. Ventricular arrhythmia: history of sustained ventricular tachycardia or any ventricular fibrillation
•2. Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
•3. Cardiac devices and implants: current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder, LA appendage closure, device or occlusion.
+30 more criteria

Locations (3)

Na Homolce Hospital

Prague, Czechia

Mater Private Hospital

Dublin, Ireland

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Key Dates

Start Date

April 3, 2024

Primary Completion Date

May 15, 2025

Completion Date

June 6, 2025

Last Updated

September 17, 2025

Enrollment

ACTUAL participants

Conditions

Atrial FibrillationParoxysmal Atrial FibrillationPersistent Atrial Fibrillation

Interventions

Ablation Treatment

DEVICE

The CONFORM Pivotal Trial

NCT05147792

Atrial FibrillationStroke

View study

RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

NCT06935591

Atrial Fibrillation (AF)

View study

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study on the FARAVIEW Technology

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Medtronic Terminate AF Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia