Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

CardioFocus

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: Endoscopically Guided Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196923

25-2858

Details and patient eligibility

About

The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Enrollment: 20 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
• 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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20 participants in 1 patient group

HeartLight Ablation

Experimental group

Treatment:

Device: Endoscopically Guided Ablation