RecruitingNot ApplicableNCT03168659
CardioFocus HeartLight Post-Approval Study
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Sponsor
CardioFocus
Enrollment
250 participants
Start Date
Jun 16, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- years or older
- planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
- failure of at least one anti-arrhythmic drug
- others
Exclusion Criteria1
- overall good health as established by multiple criteria
Interventions
DEVICEHeartLight
HeartLight Endoscopic Ablation System
PROCEDUREAblation
Pulmonary vein isolation ablation
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT03168659
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