CardioFocus HeartLight Post-Approval Study



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/10/2018
Start Date:June 16, 2017
End Date:April 2022
Contact:Study Director
Email:lhausmann@cardiofocus.com
Phone:508-658-7253

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Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation

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.

Inclusion Criteria:

- 18 years or older

- planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation

- failure of at least one anti-arrhythmic drug

- others

Exclusion Criteria:

- overall good health as established by multiple criteria
We found this trial at
4
sites
New York, New York 10029
Principal Investigator: Srini Dukkipati, MD
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New York, NY
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: J. Michael Mangrum, MD
Phone: 434-982-6401
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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from
Charlottesville, VA
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Erik Wissner, MD
Univ of Illinois A major research university in the heart of one of the world's...
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mi
from
Chicago, IL
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1501 North Campbell Avenue
Tucson, Arizona 85724
Principal Investigator: Mathew Hutchinson, MD
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from
Tucson, AZ
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