Feasibility Study of the FARAFLEX Mapping and PFA System

NCT06510556 | Recruiting

• 1 other identifier: PF306
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 4

Brief Summary

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).

Conditions

Atrial Fibrillation; Paroxysmal AF; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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).

  Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 360

• 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).

  At the end of the ablation procedure

Study Arms (2)

FARAFLEX Treatment group

OTHER

200 subjects scheduled to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with FARAFLEX mapping PFA catheter and other BSC devices.

Device: FARAFLEX Ablation Treatment

Commercial sub-study group

OTHER

Approximately 50 subjects meeting study eligibility requirements will be enrolled in a commercial sub-study at a subset of centers and will undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with a commercially approved PFA systems.

Device: Commercial Sub-study Treatment

Interventions

FARAFLEX Ablation Treatment DEVICE

Subjects 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.

FARAFLEX Treatment group

Commercial Sub-study Treatment DEVICE

Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using a commercially available 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, per the selected catheter's IFU and in accordance with the guidelines.

Commercial sub-study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Current left atrial thrombus
• History of sustained ventricular tachycardia or any ventricular fibrillation AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion
• Valvular disease that is symptomatic or is the cause of heart failure.
• Hypertrophic cardiomyopathy
• Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• Known inability to obtain vascular access or other contraindication to femoral access
• Rheumatic heart disease
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Known allergic drug reaction to nitroglycerin1
• Known severe non-revascularizable coronary disease

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

UZ Brussel Hospital

Brussels, Belgium

RECRUITING

Klinicki bolnicki centar Split

Split, Croatia

RECRUITING

Nemocnice Na Homolce Hospital

Prague, Czechia

RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sharda Mehta

CONTACT

800-227-3422; sharda.mehta@bsci.com

Maria Grazia Pietropaolo

CONTACT

+393463514999; MariaGrazia.Pietropaolo@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 200 FARAFLEX treatment subjects will be enrolled and treated with the investigational FARAFLEX™ Mapping and PFA System. Approximately 50 commercial sub-study subjects will be enrolled and treated with a commercially approved PFA system per IFU and medical guidelines.

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (1); BE (1); CZ (1); CR (1)