Feasibility Study of the FARAFLEX Mapping and PFA System
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).
| Condition(s) | Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years of age, or older if required by local law 2. Symptomatic, documented, Persistent AF or Paroxysmal AF 3. Willing and capable of providing informed consent 4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: 1. 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 ste |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Boston Scientific Corporation |
| Locations | Brussels, Belgium; Split, Croatia; Prague, Czechia; Roma, Italy |
| Start date | 2025-02-17 |
| NCT ID | NCT06510556 |
| Official listing | https://clinicaltrials.gov/study/NCT06510556 |