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.
This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
HeartLight Endoscopic Ablation System
Pulmonary vein isolation ablation
University of Arizona Sarver HeartCenter
Tucson, Arizona, United States
RECRUITINGUniversity of Illinois
Chicago, Illinois, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGThe proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period
The outcome will be assessed from 91 days post procedure through 12 months
Time frame: Day 91 through 12 months
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University Of Virginia Health System
Charlottesville, Virginia, United States
RECRUITING