ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The ACCESS Registry is an important study finding out how well special tools, called Occlutech accessory medical devices, work during heart operations. These tools help doctors fix heart conditions using a procedure with a small tube called a catheter. The study is collecting information internationally from doctors as they use these devices. They will complete surveys about how safe and easy the tools are to use, and if they perform as expected. This helps ensure these devices are reliable and safe for patients getting heart implants. It's not a study where new treatments are tested; instead, it checks the tools already in use during these common heart procedures.
At a glance
What is this study about?
Imagine doctors need to fix a problem in your heart without major surgery, using a small tube that goes through a blood vessel. To do this, they use various special tools. This study, called the ACCESS Registry, is specifically looking at some of these important tools, made by a company called Occlutech. These include items like delivery sets, pushers, and sizing balloons, which all help doctors place heart implants precisely.
The main goal of this study is to check how safe these Occlutech tools are, how well they perform their job, and how easy they are for doctors to use. It's like checking that the doctor's toolkit is in perfect working order. Doctors who use these tools during heart procedures will fill out surveys or questionnaires. These surveys ask about things like whether the procedure was successful, if there were any problems during or after the procedure, and if the tools worked well with other equipment.
This study is not testing new medicines or procedures; instead, it's a way to keep an eye on tools already in use. It helps ensure that patients undergoing heart procedures with these specific devices receive the best and safest care possible. The information gathered helps manufacturers and medical professionals continuously improve the quality and safety of these essential medical accessories.
Key takeaways
- This study evaluates tools used in certain heart operations.
- It aims to confirm the safety and performance of specific Occlutech medical devices.
- Data is collected from doctors via surveys after procedures.
- Patients do not have to do anything extra if included.
- The study helps ensure ongoing quality and safety of medical tools.
- It focuses on accessories used during heart implant procedures.
Who may be eligible?
To be included in this study, people must have had a heart procedure where certain Occlutech accessory medical devices were used. This is because the study focuses on how these specific tools perform during real-life operations.
Essentially, if you've already had a heart implant procedure involving an Occlutech accessory device, you might be included. The decision about who is included largely depends on the specific instructions for using both the heart implant and the accessory medical devices involved in your procedure.
There are no specific exclusion criteria beyond what is outlined in the instructions for using the devices themselves. This means that if the devices were used as intended according to their instructions, then you would generally be included in the study if you meet the inclusion criteria.
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.
- Did you have a heart procedure involving an implant?
- Were specific Occlutech accessory medical devices used during your procedure?
- Was your procedure carried out by an experienced doctor?
- Were the devices used according to their official instructions?
- Are you comfortable with your anonymised data contributing to medical research?
What does participation involve?
If you are included in this study, you won't need to do anything extra. This isn't a study where you visit a clinic for tests or take new medications. Instead, the doctors who performed your heart procedure will be filling out surveys about the tools they used during your operation. They will be reporting on the safety, performance, and usability of the specific Occlutech accessory devices. Your treatment will follow standard medical practice for your condition. Your personal information will be protected, and the focus is on the tools, not on you specifically as a patient.
Potential risks and benefits
Locations (36)
- Universitätsklinikum ErlangenVerified postcodeErlangen, Germany· Recruiting
- Kliniken Maria Hilf GmbHVerified postcodeMönchengladbach, Germany· Active not recruiting
- Klinikum der Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- Çukurova Üniversitesi Tıp Fakültesi Balcalı HastanesiVerified postcodeAdana, Turkey (Türkiye)· Recruiting
- İnönü Üniversitesi Tıp Fakültesi HastanesiVerified postcodeMalatya, Turkey (Türkiye)· Recruiting
- İzmir Şehir HastanesiVerified postcodeIzmir, Turkey (Türkiye)· Recruiting
- Aydın Adnan Menderes Üniversitesi HastanesiVerified postcodeAydin, Turkey (Türkiye)· Recruiting
- Bezmialem Tıp Fakültesi HastanesiVerified postcodeIstanbul, Turkey (Türkiye)· Recruiting
- Antalya Akdeniz Üniversitesi HastanesiVerified postcodeAntalya, Turkey (Türkiye)· Withdrawn
- İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma HastanesiVerified postcodeIstanbul, Turkey (Türkiye)· Recruiting
- İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma HastanesiVerified postcodeIstanbul, Turkey (Türkiye)· Recruiting
- Karaman Eğitim ve Araştırma HastanesiVerified postcodeKaraman, Turkey (Türkiye)· Recruiting
Common questions
What is the main purpose of this study?
It's checking how safe, effective, and easy to use certain tools are, which doctors use during heart procedures.
Will I need to do anything if I'm in this study?
No, you won't need to do anything extra. Your doctor will provide information based on your procedure.
Is this study testing a new drug or treatment?
No, it's not. It's looking at medical tools already in use for heart implant procedures.
What kind of heart problems are involved?
The study applies to various heart conditions treated with heart implants using a small tube (catheter).
Are there any risks to me from this study?
There are no direct risks to you, as your medical care will be exactly the same as usual.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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