Evaluating the HeartLight System for treating atrial fibrillation
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
This study is testing if the HeartLight System can safely and effectively treat people with tough-to-manage atrial fibrillation and help them feel better over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CardioFocus Industry-sponsored |
| Locations | 4 sites (Tucson, Arizona and 3 other locations) |
| Trial ID | NCT03168659 on ClinicalTrials.gov |
What this trial studies
This post-approval study aims to assess the clinical outcomes of patients treated with the HeartLight System for drug refractory, symptomatic, paroxysmal atrial fibrillation. It is a prospective, open-label, multi-center, single-arm study designed to confirm the safety and effectiveness of the HeartLight System during its commercial use. Participants will be monitored to evaluate the long-term results following catheter ablation procedures. The study seeks to provide additional data following a pivotal clinical study that initially validated the device's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for catheter ablation due to symptomatic paroxysmal atrial fibrillation and have failed at least one anti-arrhythmic drug.
Not a fit: Patients who are in overall good health and do not meet the criteria for symptomatic paroxysmal atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from atrial fibrillation who have not responded to medication.
How similar studies have performed: Other studies have shown success with similar ablation approaches for atrial fibrillation, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona and 3 other locations
- 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)
Study contacts
- Study coordinator: Study Director
- Email: lhausmann@cardiofocus.com
- Phone: 508-658-7253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.