Actively Recruiting
Feasibility Study of the FARAFLEX Mapping and PFA System
Led by Boston Scientific Corporation · Updated on 2026-05-01
250
Participants Needed
4
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).
CONDITIONS
Official Title
Feasibility Study of the FARAFLEX Mapping and PFA System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, or older if required by local law
- Symptomatic, documented persistent atrial fibrillation or paroxysmal atrial fibrillation
- 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 larger, or non-indexed volume over 100 ml
- Prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia other than right sided SVT ablation
- Current atrial myxoma
- Any pulmonary vein abnormality, stenosis, or stenting (except common and middle veins)
- Current left atrial thrombus
- History of sustained ventricular tachycardia or ventricular fibrillation due to reversible causes
- Current or planned pacemaker or defibrillator devices or other cardiac implants
- Symptomatic valvular disease or valvular disease causing heart failure
- Hypertrophic cardiomyopathy
- Any prosthetic heart valve, ring, or repair including balloon aortic valvuloplasty
- Known inability or contraindication to femoral vascular access
- Rheumatic heart disease
- Awaiting cardiac transplant or surgery within 12 months
- Known allergy to nitroglycerin
- Severe non-revascularizable coronary disease
- Pre-existing right coronary artery stent and left circumflex artery stent
- Heart failure with NYHA Class IV
- Left ventricular ejection fraction less than 40%
- Uncontrolled hypertension with systolic blood pressure over 160 mmHg or diastolic over 95 mmHg on two measurements
- Severe right ventricular dysfunction documented by echocardiography or hemodynamic data
- Within 90 days before consent: myocardial infarction, unstable or Prinzmetal angina, coronary intervention, cardiac surgery, heart failure hospitalization, pericarditis, gastrointestinal bleeding, stroke, TIA, intracranial bleeding, thromboembolic events, or carotid interventions
- Known coagulopathy disorders
- Contraindication or unwillingness to use systemic anticoagulation or acceptable alternatives
- Women of childbearing potential who are pregnant, lactating, not using medical birth control, or planning pregnancy during the study
- Body mass index over 42.0
- Solid organ or hematologic transplant or evaluation for transplant
- History or evidence of hemi-diaphragmatic paralysis or paresis
- Severe lung disease, pulmonary hypertension, abnormal blood gases, or oxygen requirement
- Renal insufficiency with eGFR less than 30 mL/min/1.73 m2 or history of dialysis or transplant
- Active malignancy except squamous cell carcinoma
- Significant gastrointestinal diseases affecting esophagus or stomach
- Active systemic infection
- Untreated severe obstructive sleep apnea
- Use of phosphodiesterase inhibitors within 24 hours before ablation
- Predicted life expectancy less than one year
- Participation in another investigational study or registry interfering with this study
- Congenital heart disease with residual abnormalities
- History of congenital methemoglobinemia
- History of G6PD deficiency
AI-Screening
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Trial Site Locations
Total: 4 locations
1
UZ Brussel Hospital
Brussels, Belgium
Actively Recruiting
2
Klinicki bolnicki centar Split
Split, Croatia
Actively Recruiting
3
Nemocnice Na Homolce Hospital
Prague, Czechia
Actively Recruiting
4
Fondazione PTV - Policlinico Tor Vergata
Roma, Italy
Actively Recruiting
Research Team
S
Sharda Mehta
CONTACT
M
Maria Grazia Pietropaolo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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