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

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

sites

Mount Sinai Hosp

New York, New York 10029

Principal Investigator: Srini Dukkipati, MD

from

New York, NY