Actively Recruiting
A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE2 PFA System in Patients With Atrial Fibrillation
Led by Boston Scientific Corporation · Updated on 2026-05-28
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of new waveforms delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). This multicenter, prospective, single-arm feasibility study aims to assess the initial safety, acute performance, and feasibility of the ablation workflow using these investigational waveforms. The study also focuses on understanding lesion durability, procedure efficiency, and waveform exposure patterns over time. The study uses the FARAWAVE PFA Catheter to deliver these investigational waveforms to isolate pulmonary veins and the posterior wall in the heart. The FARASTAR Generator works with the catheter to provide the waveforms while the FARADRIVE Steerable Sheath is used for catheter introduction into the heart chambers. This is a single-arm study, meaning all participants receive the investigational treatment, with no comparison group. Participants will undergo the ablation procedure and be monitored for device or procedure-related adverse events from the day of the procedure through 60 days afterward. The study will evaluate the success of the procedure during the ablation itself and track safety over several timepoints. Participants must attend follow-up assessments and testing at approved clinical centers to monitor outcomes and collect data related to safety and effectiveness, with the total study duration extending up to early 2028.
CONDITIONS
Brief 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 older if required by local law
- Diagnosed with Persistent or Paroxysmal Atrial Fibrillation
- Persistent AF confirmed by physician's note and ECG recordings within 180 days before enrollment
- Paroxysmal AF confirmed by physician's note and ECG within 180 days before 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 63; 5.5 cm or left atrial non-indexed volume > 100 mL
- Prior atrial ablation or atrial surgery except right-sided SVT or cavotricuspid isthmus ablation
- Current atrial myxoma or left atrial thrombus
- Pulmonary vein abnormalities, stenosis, or stenting (except common and middle pulmonary veins)
- History of sustained ventricular tachycardia or ventricular fibrillation
- Atrial fibrillation due to electrolyte imbalance, thyroid disease, alcohol, or other reversible causes
- Current or planned cardiac devices like pacemakers or implantable defibrillators
- Presence of prosthetic heart valves, moderate to severe valve disease
- Hypertrophic cardiomyopathy
- Inability to obtain vascular access or presence of IVC filter
- Planned cardiac surgery within 12 months
- Significant congenital heart disease
- Heart failure NYHA Class III or IV
- Left ventricular ejection fraction below 40%
- Body mass index over 45 kg/m2
- Known bleeding disorders or anticoagulation contraindications
- Pregnancy or lactation at time of procedure
- Severe lung disease or pulmonary hypertension
- Active malignancy (except non-melanoma skin cancers)
- Serious gastrointestinal problems affecting the esophagus or stomach
- Active systemic infection
- Untreated severe obstructive sleep apnea
- Life expectancy less than one year
- Current enrollment in conflicting investigational studies or registries
- Recent serious cardiac or vascular events within 90 days before consent
- History of organ transplantation or evaluation for transplantation
- Prior diaphragmatic paralysis or paresis
- Severe coronary disease
- Renal insufficiency with eGFR below 30 or dialysis history
- Other health conditions that may affect study participation or outcomes according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo catheter-based pulsed field ablation using the FARAPULSE™ PFA System to treat atrial fibrillation.
1 procedure visit (in-person)
Duration - Up to 60 days
Participants are monitored for safety and effectiveness after the ablation procedure.
Multiple visits up to Day 60 (in-person)
Trial Site Locations
Total: 4 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
4
Taipei Veterans General Hospital-Hospital
Taipei, Taiwan, 1127
Not Yet Recruiting
Research Team
B
Brandon Shuler
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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