NCT07444320

Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective of this feasibility study is to: * Evaluate the initial safety and acute performance of investigational waveform(s) delivered using the FARAPULSE™ PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). * Assess the feasibility of the ablation workflow and waveform delivery. * Characterize acute and chronic lesion durability, procedure efficiency, and waveform exposure patterns.

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	FARAPULSE™ Pulsed Field Ablation (PFA) System	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.

Timeline

• Start date: 2026-02-12
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-03-02
• Last updated: 2026-03-31

Locations

2 sites across 2 countries: Croatia, Czechia