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Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation

ConditionsParoxysmal Atrial Fibrillation (PAF)Persistent Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:

Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?

Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old (or older if required by local law)

Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).

Willing and capable of providing written informed consent

Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Disqualifiers

Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL

Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)

Any prior atrial surgery

Current atrial myxoma

Trial design

Design model

Single group

Treatments tested in this trial

  • FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

    Device

    Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.

Treatment groups

571 Participants
are divided into 1 treatment group
Group A: FARAFLEX Mapping and Pulsed Field Ablation (PFA) SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.

Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60.

Time frame
After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
2

The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.

Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days): * Arrhythmia: Occurrence of any Detectable Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Re-ablation: Any re-ablation for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Cardioversion: Any electrical cardioversion for Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Antiarrhythmic Drug (AAD) Use: dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new AAD.

Time frame
Day 0 through the Day 365 Assessment

Secondary outcomes

1

Atrial Arrhythmia Burden Success Endpoint

Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx.

Time frame
Post-blanking period (Day 60) through 6 months (Day 180)
2

Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint

Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure.

Time frame
Index Ablation Procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov
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