Feasibility Study of the FARAFLEX Mapping and PFA System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- FARAFLEX Ablation Treatment
- ELEVATE-COR Sub-study
Treatment groups
250 Participants
are divided into 2 treatment groupsLocations
4Belgium
UZ Brussel Hospital Brussels Belgium
Croatia
Klinicki bolnicki centar Split Split Croatia
Czechia
Nemocnice Na Homolce Hospital Prague Czechia
Italy
Fondazione PTV - Policlinico Tor Vergata Roma Italy
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov