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| Principal Investigator: | Jonathan Steinberg, MD | |
| Time frame of study: | Ongoing | |
| Time frame of participation: | One Year | |
| Number of participants needed: | 180 | |
| Location of Study: | St. Luke’s-Roosevelt |
|
| Contact Name, Number & Email: | Robin Knox, RN (212) 523-3253 |
Summary:
Clinical sites are currently recruiting patients to enroll
in the CardioFocus ENABLE pivotal clinical study of the Endoscopic Ablation
System (EAS).
This FDA-approved study is designed to assess the safety and efficacy of an investigational device for the treatment of paroxysmal atrial fibrillation (AF). As an investigational device, the EAS is only offered through this clinical study and is not commercially available. Up to 20 U.S. clinical sites will participate in the study.
The purpose of the study is to compare two types of treatment for PAF that are designed to treat the symptoms of AF. The treatments being compared are: 1. Catheter ablation with the investigational EAS, a visually-guided,
light-energy catheter
2. Standard drug therapy (antiarrhythmic drugs)
Criteria for
Participation:
Persons with paroxysmal atrial fibrillation
may be eligible for this study. Other study eligibility criteria include:
1. 18 to 65 years of age
2. Frequent episodes of AF
3. Failed 1 or 2 drug treatments for AF
Duration:
The study duration is 1 year for each
patient.
Benefits/Compensation:
The costs of study visits and all
tests related to the study are provided at no charge. There is no payment
for participation in this study.