RecruitingNot ApplicableNCT03168659

CardioFocus HeartLight Post-Approval Study

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


Sponsor

CardioFocus

Enrollment

250 participants

Start Date

Jun 16, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking real-world results of a laser-based heart procedure called pulmonary vein isolation (using the HeartLight system) to treat paroxysmal atrial fibrillation — a condition where the heart beats in an irregular, rapid rhythm that comes and goes. **You may be eligible if...** - You are 18 years or older - You have symptomatic paroxysmal atrial fibrillation (irregular heartbeat that starts and stops on its own) - At least one medication to control your heart rhythm has not worked - You are scheduled for a catheter-based heart procedure to correct the irregular rhythm **You may NOT be eligible if...** - You have certain other heart or health conditions that make this procedure unsuitable (assessed by your doctor) - You have had certain prior heart procedures or conditions affecting the pulmonary veins Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHeartLight

HeartLight Endoscopic Ablation System

PROCEDUREAblation

Pulmonary vein isolation ablation


Locations(4)

University of Arizona Sarver HeartCenter

Tucson, Arizona, United States

University of Illinois

Chicago, Illinois, United States

Mount Sinai Hospital

New York, New York, United States

University Of Virginia Health System

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT03168659


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