HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (HeartLight)
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ClinicalTrials.gov Identifier: NCT01456000 |
Recruitment Status :
Completed
First Posted : October 20, 2011
Results First Posted : September 8, 2016
Last Update Posted : September 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Paroxysmal Atrial Fibrillation | Device: EAS-AC (HeartLight) Procedure: Control Arm Ablation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 405 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: EAS-AC (HeartLight)
Treatment with the EAS-AC.
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Device: EAS-AC (HeartLight)
Pulmonary vien isolation |
Active Comparator: Control Arm Ablation
Treatment with standard ablation.
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Procedure: Control Arm Ablation
Treatment with standard ablation. |
- Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description [ Time Frame: 1 year ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456000

Study Director: | Burke Barrett | CardioFocus, Inc. (sponsor) | |
Principal Investigator: | Vivek Reddy, MD | Mt. Sinai Hospital, NYC | |
Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation |
Responsible Party: | CardioFocus |
ClinicalTrials.gov Identifier: | NCT01456000 |
Other Study ID Numbers: |
25-3002 |
First Posted: | October 20, 2011 Key Record Dates |
Results First Posted: | September 8, 2016 |
Last Update Posted: | September 8, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
atrial fibrillation AF PAF PVI |
ablation paroxysmal atrial fibrillation pulmonary vein isolation |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |