Clinical Trial TitlePost-Approval Study of the Heartlight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
National Clinical Trial Number:NCT03168659
Clinical Trial Protocol Description:
The primary objective of this post-approval study is to evaluate clinical outcomes of a recently approved device called the HeartLight System for the treatment of a heart rhythm abnormality called atrial fibrillation. Nationwide, 250 patients will be recruited for this study. At Rush University Medical Center, we expect to recruit approximately 15 patients. All participants will undergo an ablation procedure for atrial fibrillation.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a planned catheter ablation procedure due to symptomatic paroxysmal atrial fibrillation (PAF) that is refractory or intolerant to at least one Class I to IV antiarrhythmic drug.
- Have a minimum of 3 episodes of PAF within the preceding 12 months by participant history with at least one episode documented.
You will be excluded from the study if any of the following criteria apply to you:
- Have atrial fibrillation secondary to a reversible cause or non-cardiac origin.
- Have documented left thrombus on imaging (e.g., transesophageal echocardiogram, angiogram).
- Have NYHA functional Class IV heart failure.
- Have unstable angina.
This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612