RecruitingOBSERVATIONAL

Perioperative Management Evaluation in Patients With CIED

This study is investigating how people with implanted heart devices, like pacemakers or defibrillators, are cared for when they have other surgeries or procedures. Sometimes, recommendations for managing these devices during surgery are based on older information. This research aims to gather up-to-date details to understand how these devices are currently managed and what happens during and after procedures. The goal is to identify ways to make care even better and safer for patients with these important heart devices. They are looking at existing patient records and also including new patients over time.

At a glance

Status

Recruiting

Sponsor

Klinikum-Fuerth

Enrolment target

500

Start

27 Nov 2018

Estimated completion

31 Dec 2030

Cardiac Pacemaker Malfunction ICD Malfunction Cardiac Pacemaker Electrical Interference Anesthesia Complication Surgery--Complications

What is this study about?

If you have a heart device like a pacemaker or an ICD (implantable cardioverter-defibrillator), you might wonder how it's looked after if you need other surgery or a catheter procedure, such as a heart ablation. This study is all about understanding that exact process. Researchers want to see how these heart devices are managed before, during, and after other medical procedures that aren't directly related to the device itself.

The main aim is to learn more about how often any problems with these devices happen during or after other surgeries. They're also looking at what kind of care patients receive, including how their device is checked before and after a procedure, and the types of operations patients are having. This information is important because it can help doctors improve how they care for people with heart devices, making future procedures safer.

Researchers are collecting information from two hospitals. They are looking at records from patients treated since 2008 and are also including new patients as they come in for procedures. By gathering a lot of information, they hope to get a clearer picture of current practices and identify the best ways to manage heart devices during other treatments.

Key takeaways

Study looks at managing heart devices during other surgeries.
Aims to improve safety for patients with pacemakers/ICDs.
Information collected from routine patient care, no extra steps for you.
Data helps doctors refine care guidelines for the future.
Includes adults with pacemakers, ICDs, or CRT devices having unrelated surgery.
Focuses on how devices are checked before and after procedures.

Who may be eligible?

To be included in this study, you would need to be an adult (over 18 years old) who has an implanted heart device like a pacemaker, ICD, or CRT (cardiac resynchronization therapy) device.

You would also need to have had an operation or a catheter-based procedure (like an ablation) that was not directly related to your heart device. It's important that checks were done on your heart device around the time of your procedure, so the researchers can gather information about its function.

Crucially, if you don't have an implanted heart device, or if there's no information available about checks on your device around the time of your procedure, you wouldn't be included in this particular study.

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.

Are you over 18 years old?
Do you have an implanted heart device (like a pacemaker or ICD)?
Have you had or are you having surgery or a catheter procedure that isn't for your heart device?
Were checks done on your heart device around the time of that procedure?
Are you okay with researchers looking at your medical records for this information?

Answer every question to see your result.

What does participation involve?

This study is primarily looking at existing information from patient records, as well as collecting information from new patients who meet the criteria during their routine care. If you are included, you wouldn't need to do anything extra or have special appointments just for the study. The researchers will be collecting details about your health, your heart device, and your procedure from your medical notes. There are no additional medications, follow-up visits, or specific assessments required from you for this study as it observes what happens during normal medical practice.

Potential risks and benefits

This study is observational, meaning it only collects information about your existing medical care. Therefore, there are no direct medical risks or side effects associated with participating in the study itself. You won't be given any new treatments or procedures because of this research. However, the information gathered could help improve the care and safety for future patients with heart devices who need surgery. You have the right to ask questions about your data being used and can choose to withdraw your information from the study at any time without it affecting your medical care.

Locations (2)

Klinikum Fuerth
Verified postcode
Fürth, Germany· Recruiting
Klinikum Nuernberg
Verified postcode
Nuremberg, Germany· Recruiting

Common questions

What kind of heart devices are they looking at?

They're interested in all types of implanted heart devices, including pacemakers, ICDs (defibrillators), and CRT devices.

Do I need to do anything extra if I'm in this study?

No, this study just collects information from your medical records and during your routine care; you won't have any extra appointments or assessments.

What types of operations are included?

They're including any surgery or catheter-based procedure that isn't directly related to repairing your heart device itself. This could include heart surgery, vascular surgery, or ablation procedures.

Why is this study important?

It helps doctors understand the best ways to manage implanted heart devices during unrelated surgeries, which can make procedures safer for patients in the future.

Will my personal details be kept private?

Yes, all patient information collected for research studies is handled with strict confidentiality and your identity will be protected.

How to find out more

Dirk Bastian, MD

dirk.bastian@klinikum-fuerth.de +49 (0)911 7580 1101 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.