What this study is
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.
What's being tested
- HeartLight
Intervention · DEVICE
HeartLight Endoscopic Ablation System
- Ablation
Intervention · PROCEDURE
Pulmonary vein isolation ablation
Study details
- Official title
- Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
- Sponsor
- CardioFocus
- Conditions
- Atrial Fibrillation
- Enrolling
- 250 people
- Starts
- 2017-06-16
- Est. completion
- 2028-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18 years or older
- Planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
- Failure of at least one anti-arrhythmic drug
- Others
You can't join if
- Overall good health as established by multiple criteria
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUniversity of Arizona Sarver HeartCenter
Tucson, Arizona, United States
- Mathew Hutchinson, MD · Principal investigator
RecruitingUniversity of Illinois
Chicago, Illinois, United States
- Erik Wissner, MD · Principal investigator
RecruitingMount Sinai Hospital
New York, New York, United States
- Betsy Ellsworth, MSN, ANP · Contactbetsy.ellsworth@mountsinai.org
- Srini Dukkipati, MD · Principal investigator
RecruitingUniversity Of Virginia Health System
Charlottesville, Virginia, United States
- Mary Jane Strickland · Contact434-982-6401MJS7W@hscmail.mcc.virginia.edu
- J. Michael Mangrum, MD · Principal investigator
Recruiting
Study team
Sponsor
CardioFocus
Study ID 25-3944
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.