HeartLight System for Atrial Fibrillation
This study is looking at how well the HeartLight Endoscopic Ablation System works in people with atrial fibrillation (a type of irregular heartbeat). It's a follow-up study after the device has been approved for use. You might be able to join if you are 18 or older, have symptomatic paroxysmal atrial fibrillation (AFib that comes and goes and causes symptoms), and have not responded to at least one anti-arrhythmic drug. The main goal is to see what percentage of participants are free from symptomatic AFib or other fast heart rhythms for about a year after the procedure. The study aims to enroll 250 participants, but its current status is unclear.
- Study design
- This is a single-arm study, meaning all 250 participants will receive the HeartLight System treatment. It is also open-label, so both you and your doctors will know what treatment you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for symptomatic atrial fibrillation or other fast heart rhythms for 12 months after the procedure, starting 91 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CardioFocus HeartLight Post-Approval Study
At a glance
Conditions
NCT03168659
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mount Sinai Hospital
New York, New Yorkstudy coordinator listed
Recruiting
University Of Virginia Health System
Charlottesville, Virginiastudy coordinator listed
Recruiting
University of Arizona Sarver HeartCenter
Tucson, Arizonano site contact published
Recruiting
University of Illinois
Chicago, Illinoisno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- The 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 periodDay 91 through 12 months
The outcome will be assessed from 91 days post procedure through 12 months