Feasibility Study of the FARAFLEX Mapping and PFA System

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF

In brief

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).

Key facts

Study ID

NCT06510556

Run by

Boston Scientific Corporation

People needed

250

Starts

2025-02-17

Expected to finish

2027-09-15

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years of age, or older if required by local law
• Symptomatic, documented, Persistent AF or Paroxysmal 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

You may not qualify if…

• Atrial exclusions - Any of the following atrial conditions:
• Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non indexed volume >100 ml (by MRI, CT or TTE report or physician note)
• Any prior atrial endocardial, epicardial or surgical ablation procedure for atrial arrhythmia other than ablation for right sided SVT
• Current atrial myxoma
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Current left atrial thrombus
• Cardiovascular exclusions - Any of the following CV conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion
• Valvular disease that is symptomatic or is the cause of heart failure.
• Hypertrophic cardiomyopathy
• Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• Known inability to obtain vascular access or other contraindication to femoral access
• Rheumatic heart disease
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Known allergic drug reaction to nitroglycerin1
• Known severe non-revascularizable coronary disease
• Pre-existing right coronary artery stent and left circumflex artery
• Any of the following conditions at baseline:
• Heart failure associated with NYHA Class IV
• LVEF < 40%
• Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
• Any of the following events within 90 Days of the Consent Date:
• Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention

Where it is running

• UZ Brussel Hospital — Brussels, Belgium (enrolling)
• Klinicki bolnicki centar Split — Split, Croatia (enrolling)
• Nemocnice Na Homolce Hospital — Prague, Czechia (enrolling)
• Fondazione PTV - Policlinico Tor Vergata — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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