Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

NCT07444320 | Recruiting

• 1 other identifier: PF119
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

Pulsed Field Ablation

Outcome Measures

Primary Outcomes (2)

• Device or procedure-related Composite Adverse Events (CAEs)

  The incidence of device or procedure-related Composite Adverse Events (CAEs) following the Index Procedure will be evaluated.

  Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60

• Acute Procedural Success

  The proportion of subjects with percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block or confirmed by electroanatomic mapping.

  During the Ablation Procedure

Study Arms (1)

FARAPULSE™ Pulsed Field Ablation (PFA) System

OTHER

Single Arm Prospective

Device: FARAPULSE™ Pulsed Field Ablation (PFA) System

Interventions

FARAPULSE™ Pulsed Field Ablation (PFA) System DEVICE

The FARAWAVE™ PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR™ Generator will be used in conjunction with the FARAWAVE™ PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE™ Steerable Sheath will be used for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.

FARAPULSE™ Pulsed Field Ablation (PFA) System

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age, or older if required by local law
• Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation
• Persistent AF Documented:
• Physician's note confirming the presence of persistent atrial fibrillation and the arrhythmia symptoms
• Within 180 days prior to Enrollment: A 24-hour continuous ECG recording confirming continuous AF OR Two (2) ECGs from any regulatory-cleared rhythm monitoring device showing continuous AF taken at least 7 days apart.
• Paroxysmal AF Documented:
• Physician's note confirming the presence of paroxysmal atrial fibrillation and the arrhythmia symptoms
• Within 180 days of the Enrollment Date, one (1) ECG from any regulatory-cleared rhythm monitoring device showing atrial Fibrillation (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 is not available, LA non-indexed volume \> 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.
• Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation
• Any prior atrial surgery
• Current atrial myxoma
• Current Left Atrial Thrombus
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Cardiovascular Conditions - Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
• Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
• Cardiac Devices and Implants:
• Current or anticipated pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy devices.
• Interatrial baffle, patent foramen ovale, or atrial septal defect closure device or patch.
• Any Left Atrial Appendage Closure or Occlusion Device, except a WATCHMAN™ device implanted \> 90 days before Enrollment
• Valvular Disease - Presence of any of the following:
• Any prosthetic heart valve, ring or repair

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Klinicki Bolnicki Centar Split

Split, 21 000, Croatia

RECRUITING

Na Homolce Hospital

Prague, 15030, Czechia

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Brandon Shuler

CONTACT

+1 701 220 1710; brandon.shuler1@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: February 11, 2026
• First Posted: March 2, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CR (1); CZ (1); HK (1)