Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

CardioFocus

Status and phase: Completed; Phase 3

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: CardioFocus EAS-AC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958165

25-2738

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic, Paroxysmal atrial fibrillation (AF)
• 18 to 70 years of age
• Failure of at least one AAD
• Others

Exclusion criteria

• Generally good overall health as determined by multiple criteria
• Willing to participate in a study
• Others

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

EAS-AC

Experimental group

Description:

PVI with EAS-AC

Treatment:

Device: CardioFocus EAS-AC