Actively Recruiting
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
Led by Boston Scientific Corporation · Updated on 2026-05-05
200
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, or as required by local law
- Diagnosed with Persistent or Paroxysmal Atrial Fibrillation
- For Persistent AF: Physician confirmation and documented continuous AF by ECG or monitoring device within 180 days prior to enrollment
- For Paroxysmal AF: Physician confirmation and at least one ECG showing AF within 180 days prior to enrollment
- Willing and able to provide informed consent
- Willing and able to participate in all follow-up assessments and testing at an approved clinical center
You will not qualify if you...
- Left atrial anteroposterior diameter ≥ 5.5 cm or left atrial volume > 100 mL
- Prior atrial ablation procedures other than right-sided SVT or cavotricuspid isthmus ablation
- Prior atrial surgery
- Current atrial myxoma
- Current left atrial thrombus
- Any pulmonary vein abnormality, stenosis, or stenting (except common and middle PVs)
- History of sustained ventricular tachycardia or ventricular fibrillation
- Atrial fibrillation secondary to reversible causes like electrolyte imbalance, thyroid disease, or alcohol
- Presence of certain cardiac devices or implants including pacemakers and left atrial appendage closure devices (except WATCHMAN™ implanted > 90 days before enrollment)
- Presence of prosthetic heart valves, moderate to severe valve diseases
- Hypertrophic cardiomyopathy
- Any IVC filter or contraindication to femoral access
- Planned cardiac surgery within the next 12 months
- Congenital heart disease with significant abnormalities
- Heart failure NYHA Class III or IV
- Left ventricular ejection fraction < 40%
- Body mass index > 45 kg/m2
- Known bleeding disorders or contraindications to anticoagulation
- Pregnancy or lactation at time of procedure
- Severe lung disease or pulmonary hypertension
- Active malignancy other than non-melanoma skin cancer
- Significant gastrointestinal problems involving the esophagus or stomach
- Active systemic infection
- Untreated severe obstructive sleep apnea
- Life expectancy under one year
- Current enrollment in conflicting investigational studies
- Recent serious cardiac or neurovascular events within 90 days
- History of transplantation or diaphragmatic paralysis
- Severe coronary or renal disease
- Other general health conditions preventing safe participation or evaluation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Klinicki Bolnicki Centar Split
Split, Croatia, 21 000
Actively Recruiting
2
Na Homolce Hospital
Prague, Czechia, 15030
Actively Recruiting
3
Queen Mary Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
B
Brandon Shuler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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