PREMIUM Trial Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER PFO Occluder compared to Medical Management
| Purpose | The purpose of this research study is to compare the AMPLATZER PFO Occluder device to medicine in reducing the incidence of disabling migraine headaches which may be occurring in relation to Patent Foramen Ovale (PFO). This study is being done at medical centers across the United States. Approximately 466 subjects will be enrolled in this study. Your study participation will last for up to five years. Data will be gathered on the performance of the device to identify and evaluate any unknown adverse (bad or harmful) events from the device and to assess long term safety and effectiveness. | |||
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| Details | Study Number 20061331 |
Accepts Adults? Yes |
Accepts Children? No |
Fully Enrolled? No |
| Contacts | Principal Investigator Deborah Friedman, MD |
Contact Valerie Davis, RN, (585) 276-8734 |
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For More Information
Please call the phone number listed above and the clinical trial coordinator will contact you.

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