Amplatzer PFO Occluder Post-marketing Surveillance Study
Launched by ABBOTT MEDICAL DEVICES · Apr 14, 2020
Trial Information
Current as of July 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
The Amplatzer PFO Occluder post-marketing surveillance study is focused on monitoring the safety and effectiveness of a new medical device designed to close a small hole in the heart called a Patent Foramen Ovale (PFO). This study aims to collect information on any side effects or complications that might arise from using this device after it has been approved for clinical use. By doing this, researchers want to ensure that the device is safe for patients and works well in real-life settings.
Anyone who has been advised to consider the Amplatzer PFO Occluder may be eligible to participate in this study. The study is currently active, but it is not recruiting new participants at this time. If you do participate, you can expect to be monitored for any potential issues related to the device. It’s important to know that the study looks at people of all ages and genders, and the specific details about eligibility can be found in the instructions provided with the device. This study is a key step in making sure the PFO occluder remains a safe option for patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Refer to Amplatzer PFO occluder IFU
- Exclusion Criteria:
- • Refer to Amplatzer PFO occluder IFU
About Abbott Medical Devices
Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mita, Minato, Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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