Evaluating the HeartLight System for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.