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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FARAFLEX Ablation Treatment
DeviceSubjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using the investigational Boston Scientific FARAFLEX Mapping and Pulse Field Ablation (PFA) System, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator.
ELEVATE-COR Sub-study
DeviceSubjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using either FARAFLEX™ Mapping and PFA System or a commercially available ablation system, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator, per the selected catheter's IFU and in accordance with the guidelines.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: FARAFLEX Treatment groupOther 1 intervention
Group B: ELEVATE-COR sub-study groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Device or procedure-related Composite Serious Adverse Events (CSAEs)
the incidence of device or procedure-related Composite Serious Adverse Events (CSAEs) following the Index Procedure will be evaluated. Safety analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).
Time frame
Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 3602
Acute Procedural Success
The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and the posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block. Effectiveness analyses will be reported by AF type (Paroxysmal vs. Persistent) and treatment group (FARAFLEX vs. Commercial catheter).
Time frame
At the end of the ablation procedureSponsors and contacts
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Source ClinicalTrials.gov