AMPLATZER PFO Occluder Post Approval Study
This research is a follow-up study for a medical device called the AMPLATZER™ PFO Occluder. This small device is used to close a naturally occurring hole in the heart, known as a Patent Foramen Ovale (PFO), which some people have. The study aims to confirm that this device is both safe and works as expected for adult patients who have had a stroke and also have a PFO. It involves looking at a large number of patients in hospitals across the UK and Canada after the device has been approved for use, gathering information over several years to ensure its long-term benefits and safety are consistent.
At a glance
What is this study about?
This study is focused on a specific heart condition called a Patent Foramen Ovale, or PFO for short. A PFO is a small, flap-like opening between the upper two chambers of the heart that most people are born with, but which usually closes shortly after birth. For some, it remains open. While often harmless, in certain situations, it might be linked to unexplained strokes.
The AMPLATZER™ PFO Occluder is a small device designed to permanently close this hole. This study is a real-world check to make sure that the device continues to be safe and effective for patients who have had a stroke and are found to have a PFO. This is important because it helps doctors and patients understand the long-term impact and success of this treatment after it has been made available for general use.
The researchers will be monitoring a large group of adult patients who have received this device at many different hospitals. They will collect information over several years to confirm its benefits in preventing future strokes and to ensure there are no unexpected safety concerns. This type of study is crucial for ongoing patient care and improving medical treatments.
Key takeaways
- This study looks at a device called the AMPLATZER™ PFO Occluder.
- It helps close a small hole in the heart (PFO) after a stroke.
- The study aims to confirm the device's safety and effectiveness over time.
- Participation involves follow-up appointments for up to 5 years.
- It's for adults aged 18-60 who've had a stroke and have a PFO.
Who may be eligible?
This study is looking for adults aged between 18 and 60 who have had a type of stroke called an ischemic stroke within the last 18 months, and who also have a Patent Foramen Ovale (PFO), which is a small hole in their heart.
There are several reasons why someone might not be able to join the study. This includes if you have other serious heart conditions, such as significant issues with your heart valves or heart muscle, or if you have a history of heart attacks or unstable chest pain in the last six months. They also can't include people with certain blood clots, severe narrowing of arteries, or if you have other types of holes in your heart.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you had an ischemic stroke in the last 18 months?
- Do you have a Patent Foramen Ovale (PFO)?
- Are you between 18 and 60 years old?
- Do you have any other serious heart conditions or serious health problems?
- Are you currently pregnant or planning to become pregnant?
What does participation involve?
If you are eligible and agree to take part, you will have the AMPLATZER™ PFO Occluder fitted. After the procedure, you'll have several follow-up appointments. These will be at 1 month, 6 months, and 12 months after the device is implanted. Following this, you'll have annual check-ups for up to 5 years. These appointments are to monitor your health and ensure the device is working correctly and safely over time. The total duration of your participation in the study would be up to 5 years.
Potential risks and benefits
Locations (88)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Heart Center Research, LLCVerified postcodeHuntsville, United States
- Chandler Regional Medical CenterVerified postcodeChandler, United States
- St. Joseph's Hospital and Medical CenterVerified postcodePhoenix, United States
- Scottsdale Healthcare SheaVerified postcodeScottsdale, United States
- Pima Heart Physicians, PCVerified postcodeTucson, United States
- UAMS Medical CenterVerified postcodeLittle Rock, United States
- Kaiser Permanente Los Angeles Medical CenterVerified postcodeLos Angeles, United States
- USC University HospitalVerified postcodeLos Angeles, United States
- Ronald Reagan UCLA Medical CenterVerified postcodeLos Angeles, United States
- Sutter Medical CenterVerified postcodeSacramento, United States
- San Diego Cardiac CenterVerified postcodeSan Diego, United States
Common questions
What is a PFO?
A PFO is a small, flap-like opening between the upper two chambers of your heart that usually closes shortly after birth. In some people, it remains open.
What is the AMPLATZER™ PFO Occluder?
It's a small medical device designed to permanently close the PFO.
Why is this study being done?
This study is confirming the safety and effectiveness of the AMPLATZER™ PFO Occluder in patients after it has been approved for use, especially for those who have had a stroke.
How long will I be involved in the study?
If you join, you'll have follow-up appointments for up to 5 years after the device is implanted.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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