CardioFocus HeartLight Post-Approval Study

NCT03168659 — Not applicable, Recruiting, 250 participants, CardioFocus

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

Registry	NCT03168659
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	250 (Estimated)
Sponsor	CardioFocus (Industry)
Conditions	Atrial Fibrillation
Interventions	HeartLight, Ablation (Device, procedure)
Dates	start 2017-06-16, primary completion 2026-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2017-05-30, last updated 2024-08-20
Locations	4 sites in United States

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Other	Device: HeartLight; Procedure: Ablation	Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

HeartLight (Device): HeartLight Endoscopic Ablation System
Ablation (Procedure): Pulmonary vein isolation ablation

+Outcome measures

Primary outcomes

The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period [Day 91 through 12 months]: The outcome will be assessed from 91 days post procedure through 12 months

Other outcomes

Chronic Effectiveness [36 months]: Freedom from symptomatic AF or symptomatic atypical AFL/AT
Chronic Safety [36 months]: Reporting of adverse events
Effect of Operator Experience on primary effectiveness endpoint [36 months]: Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL/AT
Effect of Operator Experience on primary safety endpoint [36 months]: Assess relationship between operator experience and rate of Primary Adverse Events (PAE)
Safety Outcomes by Gender [12 months and 36 months]: Assess relationship between gender and rate of PAEs
Neurological Events [36 months]: Assess relationship between neurological events and procedural parameters

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country	Status
University of Arizona Sarver HeartCenter	Tucson, Arizona	United States	Recruiting
University of Illinois	Chicago, Illinois	United States	Recruiting
Mount Sinai Hospital	New York, New York	United States	Recruiting
University Of Virginia Health System	Charlottesville, Virginia	United States	Recruiting

My Notes

Public

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