Paroxysmal Atrial FibrillationIMPULSE-EVONCT07444320
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
A study testing FARAPULSE™ Pulsed Field Ablation (PFA) System in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 4 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 12 Feb 2026to Feb 2028
- Phase
- Interventional
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
- ≥ 18 years of age, or older if required by local law
- Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation
- 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 ECG 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
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- 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)
- Willing and capable of providing informed consent
- 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:
- 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.
- Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation
- Any prior atrial surgery
- Current atrial myxoma
- Current Left Atrial Thrombus
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- Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
- Cardiovascular Conditions - 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
- 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
- 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
- Cardiomyopathy - Hypertrophic cardiomyopathy
- Access Issues - Any IVC filter, known inability to obtain vascular access, or other contraindication to femoral access
- Anticipated Cardiac Surgery - Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
- Congenital Conditions - Any of the following congenital conditions:
- Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
- Baseline Conditions - Any of the following conditions at Baseline:
- Heart failure - Heart failure associated with NYHA Class III or IV
- Ejection Fraction - Most recent documented LVEF < 40% within the previous 12 months
- Obesity: Body Mass Index (BMI) > 45.0 kg/m^2
- Hematologic Condition: Known coagulopathy or bleeding disorder
- Anticoagulation Contraindication: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
- Pregnancy - Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
- Pulmonary Disease - Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
- Malignancy - Active malignancy (other than non-melanoma skin cancers)
- 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
- Infection - Known active systemic infection
- Sleep Apnea - Untreated diagnosed obstructive sleep apnea with apnea-hypopnea index classification of severe (> 30 events per hour) as per the guidelines
- Life Expectancy - Predicted life expectancy of less than one (1) year per investigator medical judgment
- Concurrent Enrollment - 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
- Any of the following events within 90 days of the Consent Date:
- Coronary disease - Myocardial infarction (MI), unstable angina or coronary intervention
- Pericardium - Pericarditis or symptomatic pericardial effusion
- GI Bleeding - Gastrointestinal bleeding
- Cardiac Surgery - Any cardiac surgery
- Neurovascular Event - Stroke, TIA, or intracranial bleeding
- Thromboembolism - Any active non-neurologic thrombus and/or thromboembolic event
- Carotid Intervention - Carotid stenting or endarterectomy
- Diabetes - Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
- Medical History - Any of the following conditions in the Medical History
- 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
- Coronary Disease - Any documented history of Prinzmetal angina or severe non-revascularizable coronary disease
- Renal Disease - 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
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar Split
Split, 21 000
Ante Borovina, anteborovina80@gmail.com
Ante Anic
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague, 15030
Marko Tichy, marko.tichy@homolka.cz
Petr Neuzil
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Alice Chan, acky@hku.hk
Hung Fat Tse
Taiwan1 site, 1 recruiting
- Not yet recruiting
Taipei Veterans General Hospital-Hospital
Taipei, 1127
Li-Wei Lo
About this study
Official title: A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation
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.
- Being tested
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Keywords
- Pulsed Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE™ Pulsed Field Ablation (PFA) SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation (PFA) System | Other | Single Arm Prospective Receives: Device: FARAPULSE™ Pulsed Field Ablation (PFA) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60
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.
Measured: During the Ablation Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444320
- Sponsor's protocol ID
- PF119
- Acronym
- IMPULSE-EVO
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No