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

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study

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.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation (PAF); Persistent Atrial Fibrillation
• Intervention / Treatment: Device: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System

• Study Type: Interventional
• Enrollment (Estimated): 571
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madalyn MacKinnon; Phone Number: 860-992-2724; Email: Madalyn.MacKinnon@bsci.com
• Study Contact Backup: Name: Sara Veraghtert; Email: Sara.Veraghtert@bsci.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Cardiac Arrhythmia Research
      • Principal Investigator: Andrea Natale, MD
      • Contact: Deb Cardinal; Email: dscardinal@austinheartbeat.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 18 years old (or older if required by local law)
2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
3. Willing and capable of providing written informed consent
4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Exclusion Criteria:

1. Any of the following atrial conditions:

   1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
   2. Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
   3. Any prior atrial surgery
   4. Current atrial myxoma
   5. Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
   6. Current left atrial thrombus

2. Any of the following cardiovascular conditions:

   1. History of sustained ventricular tachycardia or ventricular fibrillation
   2. Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)

   3. 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

   4. Clinically significant valvular disease, including:

      • Any cardiac valve prosthesis, ring, repair, or clip
      • Moderate to severe mitral stenosis
      • Moderate to severe aortic stenosis
      • Severe mitral regurgitation
      • Severe tricuspid regurgitation
   5. Hypertrophic or amyloid cardiomyopathy
   6. Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
   7. Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
   8. Severe right ventricular dysfunction per investigator assessment

3. Any of the following congenital conditions:

   1. Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies
   2. Known congenital methemoglobinemia
   3. Known G6PD deficiency

4. Any of the following medical history conditions:

   1. Solid organ or hematologic transplant, or under evaluation for transplant
   2. History or current evidence of hemi-diaphragmatic paralysis or paresis
   3. Prinzmetal angina or severe non-revascularizable coronary disease
   4. Known coagulopathy or bleeding disorder
   5. Renal insufficiency, history of dialysis, or renal transplant
   6. Known allergic reaction to nitroglycerin (excluding hypotension)
   7. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
   8. Active spinal cord stimulator

5. Any of the following baseline conditions:

   1. NYHA Class III or IV heart failure
   2. Left ventricular ejection fraction (LVEF) less than 40% within 12 months
   3. CHA2DS2-VASc score greater than or equal to 5
   4. Body mass index (BMI) greater than 45.0
   5. Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally
   6. Pregnant or lactating at time of procedure
   7. Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease
   8. Active malignancy (excluding squamous cell carcinoma)
   9. Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)
   10. Known Active systemic infection
   11. Life expectancy of less than 1 year
   12. Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)

6. Any of the following events within 90 days prior to consent:

   1. Myocardial infarction, unstable angina, or coronary intervention
   2. Pericarditis or symptomatic pericardial effusion
   3. Gastrointestinal bleeding
   4. Cardiac surgery
   5. Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding
   6. Any active non-neurologic thrombus and/or thromboembolic event
   7. Carotid stenting or endarterectomy
   8. Heart failure hospitalization
   9. Uncontrolled diabetes mellitus or HbA1c greater than 8.0%

7. Other conditions:

   1. Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices
   2. Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System; Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.; Other Names: FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter; FARAFLEX Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-blanking period (Day 60) through 6 months (Day 180)
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.	Index Ablation Procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): June 12, 2026
• Primary Completion (Estimated): June 12, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pulsed field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Therapeutics; Drug Therapy; Equipment and Supplies; Drug Delivery Systems; Catheters
• Other Study ID Numbers: PF314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes