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CardioFocus HeartLight Post-Approval Study

RECRUITINGN/ASponsored by CardioFocus
Actively Recruiting
PhaseN/A
SponsorCardioFocus
Started2017-06-16
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →

NCT03168659

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Atrial FibrillationHeart Disease

Locations4 sites

Arizona

1 site
University of Arizona Sarver HeartCenter
Tucson, Arizona, 85724
Mathew Hutchinson, MD

Illinois

1 site
University of Illinois
Chicago, Illinois, 60612
Erik Wissner, MD

New York

1 site
Mount Sinai Hospital
New York, New York, 10029
Betsy Ellsworth, MSN, ANPbetsy.ellsworth@mountsinai.org

Virginia

1 site
University Of Virginia Health System
Charlottesville, Virginia, 22908
Mary Jane Strickland434-982-6401MJS7W@hscmail.mcc.virginia.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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