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Clinical Trials in the USA / NCT03168659
Recruiting Not applicable

CardioFocus HeartLight Post-Approval Study

NCT03168659 · tracked via the Priya Life Science USA tracker
Sponsor
CardioFocus
Phase
Not applicable
Started
2017-06-16
Last updated
2024-08-20

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

HeartLightAblation

HeartLight: HeartLight Endoscopic Ablation System

Ablation: Pulmonary vein isolation ablation

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
University of Arizona Sarver HeartCenter Tucson Arizona Recruiting
University of Illinois Chicago Illinois Recruiting
Mount Sinai Hospital New York New York Recruiting
University Of Virginia Health System Charlottesville Virginia Recruiting

Other trials for the same condition

Amplatzer Amulet LAAO vs. NOAC Active, not recruiting
Tracking Results of Ablations to Combat AF Registry Generation 2 Recruiting
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation Recruiting
PULSED AF Post-Approval Study Recruiting
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03168659 on ClinicalTrials.gov ↗ ← All trials in the USA