HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

CardioFocus405 enrolled

Overview

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

405

Conditions

Paroxysmal Atrial Fibrillation

Interventions

EAS-AC (HeartLight)DEVICE

Pulmonary vien isolation

Control Arm AblationPROCEDURE

Treatment with standard ablation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 to 75 years. * paroxysmal atrial fibrillation * failure of at least one AAD * others Exclusion Criteria: * overall good health as established by multiple criteria

Locations (21)

University of Alabama, Birmingham

Birminham, Alabama, United States

Outcomes

Primary Outcomes

Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description

Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.

Time frame: 1 year

Data from ClinicalTrials.gov

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