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

Part of paid clinical trials in Austin, Texas.

Sponsor
Boston Scientific Corporation
Study ID
NCT07575269
Status
Recruiting
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Conditions

  • Paroxysmal Atrial Fibrillation (PAF)
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 12, 2026
Status verified
May 2026
Primary completion
Jun 12, 2028
Completion
Jan 1, 2030

Study Design

Enrollment
571 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
    Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy.

Primary Outcome Measure

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. [ Time Frame: After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Cardiac Arrhythmia ResearchAustinTexas78705
Deb Cardinal
[email protected]
Andrea Natale, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Texas Cardiac Arrhythmia Research· Austin, TX

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