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RECRUITING
NCT06510556
NA

Feasibility Study of the FARAFLEX Mapping and PFA System

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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).

Official title: Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-02-17

Completion Date

2027-09-15

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DEVICE

FARAFLEX Ablation Treatment

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.

DEVICE

Commercial Sub-study Treatment

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.

Locations (4)

UZ Brussel Hospital

Brussels, Belgium

Klinicki bolnicki centar Split

Split, Croatia

Nemocnice Na Homolce Hospital

Prague, Czechia

Fondazione PTV - Policlinico Tor Vergata

Roma, Italy