Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF (VISION AF)

CardioFocus

Status: Enrolling

Conditions: Atrial Fibrillation (Paroxysmal)

Treatments: Device: pulsed field ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06828939

25-6073

Details and patient eligibility

About

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Full description

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent symptomatic PAF with at least one documented episode
• Failure or intolerance of at least one AAD
• Age 18-75 years
• Patient is indicated for an ablation procedure according to society guidelines or study site practice
• Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion criteria

• overall good health as established by multiple criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Treatment Arm

Experimental group

Description:

The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System

Treatment:

Device: pulsed field ablation