At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
EAS-AC (HeartLight) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
In Brief
A Phase 3 clinical trial evaluating EAS-AC (HeartLight) and Control Arm Ablation for Paroxysmal Atrial Fibrillation. Completed, enrolled 405 participants across 21 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartJan 2012
Primary CompletionDec 2014
Study CompletionJan 2016
TodayJul 2026
First PostedOct 20, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.7 years ago
Interventions
EAS-AC (HeartLight)device
Pulmonary vien isolation
Control Arm Ablationprocedure
Treatment with standard ablation.