Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

ConditionsParoxysmal Atrial Fibrillation Persistent Atrial Fibrillation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBoston Scientific Corporation

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age, or older if required by local law

Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: FARAPULSE™ Pulsed Field Ablation (PFA) SystemOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

During the Ablation Procedure