Feasibility Study on the FARAVIEW Technology

NCT06175234 | Completed

• 1 other identifier: PF305
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  At the end of the ablation procedure

Other Outcomes (2)

• Number of subjects presenting with PV or PW reconnections (NAVIGATE PF Phase 2 only)

  Day-60 remapping procedure

• Comparison of electro-anatomical maps (NAVIGATE PF Phase 2 only)

  Day-60 remapping procedure

Study Arms (1)

Catheter ablation for Paroxysmal or Persistent Atrial Fibrillation

OTHER

Subjects scheduled to undergo endocardial mapping and Pulmonary Vein Isolation (PVI) in the treatment of atrial fibrillation. For patients with persistent AF, left atrial posterior wall isolation (PWI) may also be performed in addition to PVI at the discretion of the investigator

Device: Ablation Treatment

Interventions

Ablation Treatment DEVICE

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.

Catheter ablation for Paroxysmal or Persistent Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years of age, or older if required by local law
• Symptomatic, documented, drug-resistant, Atrial Fibrillation
• 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
• Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I, II, III or IV) 1
• Informed consent: willing and capable of providing informed consent
• 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

You may not qualify if:

• 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
• Atrial myxoma: current atrial myxoma
• Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Atrial thrombus: current left atrial thrombus
• Long standing persistent AF: continuous AF lasting longer than 12 months
• Ventricular arrhythmia: history of sustained ventricular tachycardia or any ventricular fibrillation
• Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• 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.
• Clinically significant valvular disease: valvular disease that is any of the following:
• i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Cardiomyopathy i. Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Access issues: any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic disease: rheumatic heart disease i. Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Any of the following conditions at baseline (Section 10.4):
• Heart failure NYHA Heart failure associated with NYHA IV
• Ejection fraction: LVEF \< 40%
• Any of the following events within 90 Days of the Consent Date:
• Coronary disease: myocardial infarction (MI), unstable or coronary intervention

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Na Homolce Hospital

Prague, 15030, Czechia

Location

Mater Private Hospital

Dublin, 7 D07 RD8P, Ireland

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• Garcia-Bolao I, Reddy VY, Su WW, Koruth JS, Fitzpatrick N, Neuzil P, Rincon RA, Canepa S, Kang K, Oesterlein T, Koop BE, Metzdorff C, Okeson B, Gutbrod SR, Szeplaki G. Visualization of PFA During PVI With the Second-Generation Pentaspline Catheter: NAVIGATE-PF Phase 1 Results. JACC Clin Electrophysiol. 2025 Dec 30:S2405-500X(25)00998-3. doi: 10.1016/j.jacep.2025.11.016. Online ahead of print.

  PMID: 41474406 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 18, 2023
• Study Start: April 3, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 6, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

ES (1); IE (1); CZ (1)