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
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).
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 →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.
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.
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.
Exclusion Criteria:
Any of the following atrial conditions:
Any of the following cardiovascular conditions:
Any of the following conditions at Baseline:
Any of the following events within 90 days of the Consent Date:
Any of the following conditions in the Medical History
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.
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
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.
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.
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.
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.
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 (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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
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
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
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.
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 ↗
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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