Feasibility Study on the FARAVIEW Technology

Last updated: September 16, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Arrhythmia

Treatment

Ablation Treatment

Clinical Study ID

NCT06175234
PF305
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: ≥ 18 years of age, or older if required by local law

  2. Symptomatic, documented, drug-resistant, Atrial Fibrillation

  3. Documented: at a minimum a physician's note confirming the arrhythmia symptomsand durations AND within 180 days of the Enrollment Date one (1) ECG from anyregulatory cleared rhythm monitoring device showing AF

  4. Drug-resistant: effectiveness failure of, intolerance to, or specificcontraindication to at least one (1) AAD (Class I, II, III or IV) 1

  5. Informed consent: willing and capable of providing informed consent

  6. Full participation: willing and capable of participating in all follow-upassessments and testing associated with this clinical investigation at an approvedclinical investigational center

Exclusion

Exclusion Criteria:

  1. Atrial exclusions - Any of the following atrial conditions:

  2. Prior atrial ablation: any prior atrial endocardial, epicardial or surgicalablation procedure for arrhythmia other than ablation for right sided SVT orcavotricuspid isthmus ablation

  3. Atrial myxoma: current atrial myxoma

  4. Pulmonary veins: any PV abnormality, stenosis, or stenting (common and middlePVs are admissible)

  5. Atrial thrombus: current left atrial thrombus

  6. Long standing persistent AF: continuous AF lasting longer than 12 months

  7. Cardiovascular exclusions - Any of the following CV conditions:

  8. Ventricular arrhythmia: history of sustained ventricular tachycardia or anyventricular fibrillation

  9. Secondary AF: AF that is secondary to electrolyte imbalance, thyroid disease,alcohol, or other reversible / non-cardiac causes

  10. Cardiac devices and implants: current or anticipated pacemaker, implantablecardioverter defibrillator or cardiac resynchronization therapy devices,interatrial baffle, closure device, patch, or patent foramen ovale or ASDoccluder, LA appendage closure, device or occlusion.

  11. Clinically significant valvular disease: valvular disease that is any of thefollowing: i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associatedwith abnormal LV function or hemodynamic measurements e. Cardiomyopathy i.Hypertrophic cardiomyopathy ii. Cardiac amyloidosis f. Valve prostheses: anyprosthetic heart valve, ring or repair including balloon aortic valvuloplasty g.Access issues: any IVC filter, known inability to obtain vascular access or othercontraindication to femoral access h. Rheumatic disease: rheumatic heart disease i.Anticipated cardiac surgery: awaiting cardiac transplantation or other cardiacsurgery within the next 12 months

  12. Any of the following conditions at baseline (Section 10.4):

  13. Heart failure NYHA Heart failure associated with NYHA IV

  14. Ejection fraction: LVEF < 40%

  15. Any of the following events within 90 Days of the Consent Date:

  16. Coronary disease: myocardial infarction (MI), unstable or coronary intervention

  17. Cardiac surgery: any cardiac surgery

  18. Heart failure hospitalization: heart failure hospitalization

  19. Pericardium: pericarditis or symptomatic pericardial effusion

  20. GI bleeding: gastrointestinal bleeding

  21. Neurovascular event: stroke, TIA, or intracranial bleeding

  22. Thromboembolism: any non-neurologic thromboembolic event

  23. Carotid intervention: carotid stenting or endarterectomy

  24. Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting orbleeding diathesis

  25. Contraindication to anticoagulation: contraindication to, or unwillingness to use,systemic anticoagulation

  26. Pregnancy: women of childbearing potential who are pregnant, lactating, not usingmedical birth control or who are planning to become pregnant during the anticipatedstudy period

  27. Health conditions that in the investigator's medical opinion would preventparticipation in the study, interfere with assessment or therapy, significantlyraise the risk of study participation, or modify outcome data or its interpretation,including but not limited to:

  28. Obesity: Body Mass Index (BMI) > 45.0

  29. Transplantation: solid organ or hematologic transplant, or currently beingevaluated for a transplant

  30. Diaphragmatic abnormality: any prior history or current evidence ofhemi-diaphragmatic paralysis or paresis

  31. Pulmonary: severe lung disease, pulmonary hypertension, or any lung diseaseinvolving abnormal blood gases or requiring supplemental oxygen

  32. Renal: renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renaltransplant

  33. Malignancy: active malignancy (other than cutaneous basal cell or squamous cellcarcinoma)

  34. Gastrointestinal: clinically significant gastrointestinal problems involvingthe esophagus or stomach including severe or erosive esophagitis, uncontrolledgastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenalulceration

  35. Infections: active systemic infection

  36. COVID-19 disease: known positive test for COVID-19 and disease not clinicallyresolved

  37. Life expectancy: predicted life expectancy less than one (1) year

  38. Participation in another trial: subjects who are currently enrolled in anotherinvestigational study or registry that would directly interfere with the currentstudy, except when the subject is participating in a mandatory governmentalregistry, or a purely observational registry with no associated treatments; eachinstance must be brought to the attention of the Sponsor to determine eligibility

  39. Congenital heart disease: congenital heart disease with any clinically significantresidual anatomic or conduction abnormality

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Ablation Treatment
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
June 06, 2025

Study 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.

Connect with a study center

  • Na Homolce Hospital

    Prague, 15030
    Czechia

    Site Not Available

  • Na Homolce Hospital

    Prague 3067696, 15030
    Czechia

    Site Not Available

  • Mater Private Hospital

    Dublin, 7 D07 RD8P
    Ireland

    Site Not Available

  • Mater Private Hospital

    Dublin 2964574, 7 D07 RD8P
    Ireland

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

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