NCT07575269

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Jan 2030

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

May 4, 2026

Last Update Submit

July 24, 2026

Conditions

Paroxysmal Atrial Fibrillation (PAF)Persistent Atrial Fibrillation

Keywords

pulsed field ablation

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

    Day 0 through the Day 365 Assessment

Secondary Outcomes (2)

  • Atrial Arrhythmia Burden Success Endpoint

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

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

    Index Ablation Procedure

Study Arms (1)

FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

EXPERIMENTAL

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.

Device: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

Interventions

FARAFLEX Mapping and Pulsed Field Ablation (PFA) SystemDEVICE

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

Also known as: FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter, FARAFLEX Catheter
FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any of the following atrial conditions:
  • 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
  • Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
  • Current left atrial thrombus
  • Any of the following cardiovascular conditions:
  • History of sustained ventricular tachycardia or ventricular fibrillation
  • Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)
  • Presence of any of the following cardiac devices or implants:
  • Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
  • Current implantable loop recorder other than LUX-Dx
  • Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
  • Left atrial appendage closure or occlusion device
  • +49 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Mount Sinai Medical Center-Hospital

New York, New York, 10029, United States

RECRUITING

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

RECRUITING

Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, 75701, United States

RECRUITING

Mater Private Hospital-Hospital

Dublin, Dublin, D07 RD8P, Ireland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery SystemsCatheters

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsEquipment and Supplies

Study Officials

  • Andrea Natale, MD

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madalyn MacKinnon

CONTACT

860-992-2724Madalyn.MacKinnon@bsci.com

Sara Veraghtert

CONTACT

Sara.Veraghtert@bsci.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

July 20, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

IE(1)US(5)