CardioFocus HeartLight Post-Approval Study
Recruiting
N/A
Interventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- CardioFocus · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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
Contacts