ClinicalTrials.gg
RecruitingNCT07444320IMPULSE-EVOUpdated Oct 23, 2026

Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

An interventional study of FARAPULSE™ Pulsed Field Ablation (PFA) System in Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, sponsored by Boston Scientific Corporation. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

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

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 61 studies in Atrial Fibrillation by Boston Scientific Corporation — 8 open to participants now, 20 under way, none of them phase 3. Atrial Fibrillation · Boston Scientific Corporation.

Planned enrollment
23rd of 40
200 · median 296
Started
2026
with 4 others
No phase
34 of 61
8 open now
Primary completion
2028-02
later than 15 of 19 live
Registered
58th of 61
by date

Among the 61 studies in Atrial Fibrillation by Boston Scientific Corporation, this one is the 23rd largest by planned enrollment of the 40 interventional ones that give a count, is one of 5 that started in 2026, is one of 34 with no phase, reaches primary completion later than 15 of the 19 other live ones, and was the 58th registered.

Atrial Fibrillation

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

Browse Atrial Fibrillation studies →

Open to participants now

8 of the 61 studies in Atrial Fibrillation by Boston Scientific Corporation are open now, in 11 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Who these studies take

Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 61 studies in Atrial Fibrillation by Boston Scientific Corporation, or all of them as a file.
02

Study summary

This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).

Read the detailed description

The objective of this feasibility study is to:

  • Evaluate the initial safety and acute performance of investigational waveform(s) delivered using the FARAPULSE™ PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
  • Assess the feasibility of the ablation workflow and waveform delivery.
  • Characterize acute and chronic lesion durability, procedure efficiency, and waveform exposure patterns.
03

Conditions studied

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Browse trials for

Keywords

  • Pulsed Field Ablation
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. ≥ 18 years of age, or older if required by local law
  2. Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation

    1. Persistent AF Documented:

      • Physician's note confirming the presence of persistent atrial fibrillation and the arrhythmia symptoms
      • Within 180 days prior to Enrollment: A 24-hour continuous recording confirming continuous AF OR Two (2) ECGs from any regulatory-cleared rhythm monitoring device showing continuous AF taken at least 7 days apart.

      OR

    2. Paroxysmal AF Documented:

      • Physician's note confirming the presence of paroxysmal atrial fibrillation and the arrhythmia symptoms
      • Within 180 days of the Enrollment Date, one (1) ECG from any regulatory-cleared rhythm monitoring device showing atrial Fibrillation (AF)
  3. Willing and capable of providing
  4. 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. Atrial exclusions - any of the following atrial conditions:

    1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter is not available, LA non-indexed volume > 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.
    2. Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation
    3. Any prior atrial surgery
    4. Current atrial myxoma
    5. Current Left Atrial Thrombus
    6. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
  2. Cardiovascular Conditions - Any of the following cardiovascular conditions:

    1. History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
    2. Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
    3. Cardiac Devices and Implants:

      • 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 Closure or Occlusion Device, except a WATCHMAN™ device implanted > 90 days before Enrollment
    4. Valvular Disease - Presence of any of the following:

      • Any prosthetic heart valve, ring or repair
      • Moderate to severe mitral valve stenosis
      • More than moderate mitral regurgitation (≥ 3+)
      • Moderate to severe aortic stenosis
    5. Cardiomyopathy - Hypertrophic cardiomyopathy
    6. Access Issues - Any IVC filter, known inability to obtain vascular access, or other to femoral access
    7. Anticipated Cardiac Surgery - Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
  3. Congenital Conditions - Any of the following congenital conditions:

    a. Congenital heart disease with any residual anatomic or conduction abnormality

  4. Baseline Conditions - Any of the following conditions at Baseline:

    1. Heart failure - Heart failure associated with Class III or IV
    2. - Most recent documented LVEF \< 40% within the previous 12 months
    3. Obesity: (BMI) > 45.0 kg/m\^2
    4. Hematologic Condition: Known coagulopathy or bleeding disorder
    5. Anticoagulation Contraindication: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
    6. Pregnancy - Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
    7. Pulmonary Disease - Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
    8. - Active malignancy (other than non-melanoma skin cancers)
    9. 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
    10. Infection - Known active systemic infection
    11. Sleep Apnea - Untreated diagnosed obstructive sleep apnea with apnea-hypopnea index classification of severe (> 30 events per hour) as per the guidelines
    12. - Predicted life expectancy of less than one (1) year per investigator medical judgment
    13. Concurrent Enrollment - 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:

    1. Coronary disease - Myocardial infarction (MI), unstable angina or coronary intervention
    2. Pericardium - Pericarditis or symptomatic pericardial effusion
    3. GI Bleeding - Gastrointestinal bleeding
    4. Cardiac Surgery - Any cardiac surgery
    5. Neurovascular Event - Stroke, , or intracranial bleeding
    6. Thromboembolism - Any active non-neurologic thrombus and/or thromboembolic event
    7. Carotid Intervention - Carotid stenting or endarterectomy
    8. Diabetes - Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
  6. Medical History - Any of the following conditions in the Medical History

    1. Transplantation - Solid organ or hematologic transplant, or currently being evaluated for a transplant
    2. Diaphragmatic Abnormality - Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
    3. Coronary Disease - Any documented history of Prinzmetal angina or severe non-revascularizable coronary disease
    4. Renal Disease - Renal insufficiency if an estimated (eGFR) is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant
    5. General Medical Conditions - 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(12)

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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
    FARAPULSE™ Pulsed Field Ablation (PFA) System

    Single Arm Prospective

    Device: FARAPULSE™ Pulsed Field Ablation (PFA) System

Interventions

  • DeviceFARAPULSE™ Pulsed Field Ablation (PFA) System

    The FARAWAVE™ PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR™ Generator will be used in conjunction with the FARAWAVE™ PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE™ Steerable Sheath will be used for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.

06

What researchers measure

Primary outcomes

  1. Device or procedure-related Composite Adverse Events (CAEs)

    The incidence of device or procedure-related Composite Adverse Events (CAEs) following the Index Procedure will be evaluated.

    Time frame: Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60

  2. Acute Procedural Success

    The proportion of subjects with percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block or confirmed by electroanatomic mapping.

    Time frame: During the Ablation Procedure

07

Study locations

3 of 4 sites recruiting
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

Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.

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 24 months is close to 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
Feb 11, 2026
First posted
Mar 2, 2026
StartActual
Feb 12, 2026
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2028
Last update
Oct 23, 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.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Minor edits only
    + 1 other change: verification date

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
NCT07444320
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Feb 12, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Brandon Shuler
Contact
brandon.shuler1@bsci.com
+1 701 220 1710

Oversight

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

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