AzTrials
AzTrials

Atrial FibrillationNAVIGATE PFNCT06175234

Feasibility Study on the FARAVIEW Technology

A study testing Ablation Treatment in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ablation Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesin 3 countries
Study dates
3 Apr 2024to 6 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Atrial exclusions - Any of the following atrial conditions:
  • 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
Show all 40Show fewer
  • Cardiovascular exclusions - Any of the following CV conditions:
  • 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:
  • 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
  • Cardiac surgery: any cardiac surgery
  • Heart failure hospitalization: heart failure hospitalization
  • Pericardium: pericarditis or symptomatic pericardial effusion
  • GI bleeding: gastrointestinal bleeding
  • Neurovascular event: stroke, TIA, or intracranial bleeding
  • Thromboembolism: any non-neurologic thromboembolic event
  • Carotid intervention: carotid stenting or endarterectomy
  • Bleeding diathesis: thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis
  • Contraindication to anticoagulation: contraindication to, or unwillingness to use, systemic anticoagulation
  • Pregnancy: women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period
  • Health conditions that in the investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
  • Obesity: Body Mass Index (BMI) > 45.0
  • Transplantation: solid organ or hematologic transplant, or currently being evaluated for a transplant
  • Diaphragmatic abnormality: any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
  • Pulmonary: severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • 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 renal transplant
  • Malignancy: active malignancy (other than cutaneous basal cell or squamous cell carcinoma)
  • Gastrointestinal: clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
  • Infections: active systemic infection
  • COVID-19 disease: known positive test for COVID-19 and disease not clinically resolved
  • Life expectancy: predicted life expectancy less than one (1) year
  • Participation in another trial: subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
  • Congenital heart disease: congenital heart disease with any clinically significant residual anatomic or conduction abnormality

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Czechia1 site

  • Na Homolce Hospital

    Prague, 15030

Other trials in Czechia

Ireland1 site

  • Mater Private Hospital

    Dublin, 7 D07 RD8P

Other trials in Ireland

Spain1 site

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: 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

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.

Read the 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.

Being tested
Ablation Treatment
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation TreatmentDevice

    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.

Study groups in NCT06175234
Study groupRoleWhat they receive
Catheter ablation for Paroxysmal or Persistent Atrial FibrillationOtherSubjects 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
Receives: Device: Ablation Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At the end of the ablation procedure

  2. 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

    Measured: At the end of the ablation procedure

  3. 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.

    Measured: At the end of the ablation procedure

  4. 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.

    Measured: At the end of the ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start3 Apr 2024
  3. Primary completion15 May 2025
  4. Study completion6 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175234
Sponsor's protocol ID
PF305
Acronym
NAVIGATE PF
Status last verified
Sep 2025
First submitted
27 Nov 2023
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Reddy VY, Petru J, Funasako M, Canepa S, Metzdorff C, Okeson B, Mikos E, Oesterlein T, Gutbrod SR, Koop BE, Neuzil P. Lesion Durability of the Second Generation Pentaspline Pulsed Field Ablation Catheter NAVIGATE-PF Phase 2 Results. Circ Arrhythm Electrophysiol. 2026 Apr;19(4):e014477. doi: 10.1161/CIRCEP.125.014477. Epub 2026 Apr 1.

    PubMed 41919393

  • 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. 2026 Apr;12(4):802-813. doi: 10.1016/j.jacep.2025.11.016. Epub 2025 Dec 30.

    PubMed 41474406

Questions about this trial

What is this clinical trial studying?

A study testing Ablation Treatment in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia, Ireland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with PVI success (time frame: At the end of the ablation procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06175234, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in