This trial is active, not recruiting.

Condition paroxysmal atrial fibrillation
Treatments eas-ac (heartlight), control arm ablation
Phase phase 3
Sponsor CardioFocus
Start date January 2012
End date October 2013
Trial size 450 participants
Trial identifier NCT01456000, 25-3002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Treatment with the EAS-AC.
eas-ac (heartlight)
Pulmonary vien isolation
(Active Comparator)
Treatment with standard ablation.
control arm ablation
Treatment with standard ablation.

Primary Outcomes

Freedom for documented, symptomatic atrial fibrillation
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
Principal investigator Vivek Reddy, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by CardioFocus.