ClinicalTrials.gg
Not yet recruitingNCT07925359NAVigate-ULTRAUpdated Nov 9, 2026

The Evaluation of User Experience With FARAVIEW™ Technology of the OPAL HDx™ Mapping System When Used With the FARAWAVE NAV™ ULTRA Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation

An interventional study of Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping System in Atrial Fibrillation (AF), Paroxysmal AF and Persistent Atrial Fibrillation (PersAF), sponsored by Boston Scientific Corporation. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to obtain experience with new and modified components of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used with the OPAL HDx™ Mapping System for the treatment of Atrial Fibrillation (AF).

02

Conditions studied

  • Atrial Fibrillation (AF)
  • Paroxysmal AF
  • Persistent Atrial Fibrillation (PersAF)
  • FARAPULSE

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Keywords

  • Pulsed Field Ablation
  • Pulmonary Vein Isolation
  • Posterior Wall Isolation
  • Mitral Ishtmus Ablation
  • Cavotricuspid Ishtmus Ablation
  • Superior Vena Cava Isolation
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At least 18 years old, or older if required by law.
  2. Subjects meeting criteria for Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation per the IFU.
  3. Subjects must be either de novo subjects: left atrial catheter ablation procedure performed for the treatment of atrial fibrillation.

    OR redo subjects: i. A single prior catheter ablation procedure for the treatment of atrial fibrillation is permitted.

    ii. The prior ablation procedure must have been limited to documented Pulmonary Vein Isolation (PVI) and/or documented Posterior Wall Isolation (PWI) only iii. Right atrial-only procedures for CTI-dependent flutter do not count as prior atrial fibrillation ablation procedures.

  4. Willing and capable of providing
  5. Willing and capable of participating in all follow up assessments and testing associated with this clinical investigation at an approved clinical center

Exclusion criteria

Exclusion Criteria:

  1. Any of the following atrial conditions:

    • Left atrial anteroposterior diameter ≥ 6.5 cm, or if LA diameter not available, non-indexed volume > 250 mL
    • Any prior atrial surgery
    • Current atrial myxoma
    • Current Left Atrial Thrombus
    • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  2. Any of the following cardiovascular conditions:

    • History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
    • Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
    • Current or anticipated pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy devices. Interatrial baffle, patent foramen ovale, or atrial septal defect closure device or patch. Any Left Atrial Appendage (LAA) Closure or Occlusion Device.
    • Presence of any of the following: Any cardiac valve prosthesis, ring, repair or clip, Mitral valve stenosis: moderate or greater, Aortic stenosis: moderate or greater, Severe mitral regurgitation, Severe tricuspid regurgitation
    • Hypertrophic Cardiomyopathy
    • Any IVC filter, known inability to obtain vascular access or other to femoral access
    • Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
  3. Any of the following congenital conditions: Congenital heart disease with any residual anatomic or conduction abnormality
  4. Any of the following conditions at Baseline:

    • Heart failure associated with Class III and IV
    • Most recent documented \< 40% within the previous 12 months
    • (BMI) > 45.0 kg/m2
    • Known coagulopathy or bleeding disorder
    • Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
    • Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
    • Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
    • Active (other than non-melanoma skin cancers)
    • Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
    • Known active systemic infection
    • Predicted of less than one (1) year per investigator medical judgement
    • Subjects who are currently enrolled in another 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
  5. Any of the following events within 90 days of the Consent Date:

    • Myocardial infarction (MI), unstable angina or coronary intervention
    • Pericarditis or symptomatic pericardial effusion
    • Gastrointestinal bleeding
    • Any Cardiac Surgery
    • Stroke, , or intracranial bleeding
    • Any active non-neurologic thrombus and/or thromboembolic event
    • Carotid stenting or endarterectomy
    • Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
  6. Any of the following conditions in the Medical History

    • Solid organ or hematologic transplant, or currently being evaluated for a transplant
    • Any prior history or current evidence of hemidiaphragmatic paralysis or paresis
    • Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease
    • Renal insufficiency if an estimated (eGFR) is \< 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
    • Known allergic drug reaction to nitroglycerin (excluding hypotension)
    • Any other general 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
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Treatment Group: Ablation Procedure

    Up to approximately 200 subjects scheduled to undergo catheter-based endocardial mapping and ablation in the treatment of paroxysmal or persistent atrial fibrillation (de novo or redo subject) with the new and modified components of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used with the OPAL HDx™ Mapping System.

    Device: Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping System

Interventions

  • DeviceAblation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping System

    Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of paroxysmal or persistent atrial fibrillation (de novo or redo subjects). Using the investigational new and modified components of Boston Scientific FARAPULSE Pulsed Field Ablation (PFA) System and OPAL HDx Mapping System, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall (LAPW), cavo-tricuspid isthmus (CTI ), mitral isthmus (MI) and/or superior vena cava (SVC) is at the discretion of the investigator.

06

What researchers measure

Primary outcomes

  1. Incidence of device-related or procedure-related events of a serious nature

    Safety will be assessed for subjects who undergo ablation using the investigational system configuration of the FARAPULSE™ PFA System during the Index Procedure or any repeat PFA procedure using the investigational system configuration. Safety will be characterized descriptively by the incidence of device-related or procedure-related events of a serious nature with onset dates within the follow-up intervals: Day 0-7; Day 0-30; Day 0-60.

    Time frame: Day 0 (ablation procedure) - Day 7; Day 0 - Day 30; Day 0 - Day 60

  2. Acute Procedural Success for PV and LAPW Isolation

    * The proportion of de novo subjects that achieve acute procedural success (APS) defined as percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and left atrial posterior wall (LAPW) during the index procedure. * The proportion of redo subjects that achieve acute procedural success defined as percutaneous endocardial creation of touch-up lesions required for re-isolation of the PVs and LAPW during the Index Procedure. APS will be clinically assessed by entrance and/or exit block or confirmed by electroanatomical mapping for the PVs and by the site's standard of care method for LAPW. Redo subjects not requiring PV ablation will be excluded from the evaluation of acute PV isolation success.

    Time frame: At the end of the ablation procedure

  3. Acute Procedural Success for CTI, MI and SVC Ablation

    * The proportion of subjects undergoing cavotricuspid (CTI) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom bidirectional conduction block across the CTI line is achieved during the Index procedure. * The proportion of subjects undergoing mitral isthmus (MI) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom conduction block across the MI line is achieved during the Index procedure. * The proportion of subjects undergoing superior vena cava (SVC) ablation using the FARAWAVE NAV Ultra PFA Catheter in whom electrical isolation of the SVC is achieved during the Index procedure. Acute procedural success for CTI, MI, and SVC ablation lesions will be assessed according to each study site's standard-of-care method.

    Time frame: At the end of the ablation procedure

  4. Acute Procedural Success - Timing

    Acute procedural effectiveness will be evaluated using procedural performance measures, including but not limited ablation time per lesion set, total procedure time, fluoroscopy time, left atrial dwell time, and transseptal access timing, assessed during the Index Procedure.

    Time frame: At the end of the ablation procedure

07

Study locations

3 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Oct 2027, 9 months later.

Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 9 months is below that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Nov 9, 2026
StartEst.
Jan 20, 2027
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07925359
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jan 20, 2027 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Björk Van den Bogaert
Contact
bjoerk.vandenbogaert@bsci.com
+32477059181
Sharon Mensah
Contact
Sharon.Mensah@bsci.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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