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

Phase 4CompletedNCT01196923

CardioFocus20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Endoscopically Guided AblationDEVICE

Visually Guided Ablation using EAS-AC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro Cardiologico Monzino

Milan, Italy

Outcomes

Primary Outcomes

Acute Isolation of Pulmonary Veins.

99% of pulmonary veins were isolated (72/73)

Time frame: Acute PVI measured on the day of treatment

Data from ClinicalTrials.gov

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