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

CardioFocus100 enrolled

Overview

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Paroxysmal Atrial Fibrillation

Interventions

CardioFocus HeartLight Endoscopic Ablation SystemDEVICE

PVI ablation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 to 70 years * paroxysmal atrial fibrillation * failure of at least one AAD * others Exclusion Criteria: * overall good health as established by multiple criteria

Locations (10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Pacific Heart Institute

Santa Monica, California, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Outcomes

Primary Outcomes

Freedom From Recurrence of Atrial Fibrillation

Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.

Time frame: 12 months

Data from ClinicalTrials.gov

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