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Registry of Device Implantation

This study is gathering information about common heart devices, such as pacemakers and defibrillators, that help people with heart rhythm problems or severe heart failure. These devices have been used for a long time, and new types are still being developed. The main goal is to understand how well these devices work and how safe they are for patients. Researchers are looking at different factors, like a patient's health information before surgery and details of the implantation procedure itself. By identifying what leads to good results or potential complications, this study hopes to find ways to make patient care even better in the future. It's about ensuring patients get the best possible treatment for their heart conditions.

At a glance

Status
Recruiting
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Enrolment target
2,000
Start
01 Jan 2011
Estimated completion
01 Dec 2030

What is this study about?

You might have heard of pacemakers or even have one yourself. These devices are used in hospitals every day to help people whose hearts beat too slowly, too fast, or who have other serious heart problems. Over the years, these devices have become very important for keeping people healthy and even saving lives.

This study, called a 'registry,' is like a detailed record-keeping system. Medical teams are collecting information from many patients who have received various types of heart devices. These include familiar ones like pacemakers, which help a slow heart beat normally, and defibrillators, which can stop dangerously fast heartbeats. They're also looking at newer devices that help with severe heart failure or continuously monitor heart rhythms for unusual activity.

The main idea behind this registry is to make sure these treatments are as good as they can be. By carefully tracking information from patients, doctors hope to learn what makes a treatment most effective and safest. They're trying to figure out which specific patient characteristics or details about the procedure might lead to better health outcomes or help prevent problems down the road. Ultimately, all this information will help doctors improve care for everyone who needs these life-changing heart devices.

Key takeaways

  • This study collects data on common heart devices to improve patient care.
  • It aims to understand what makes heart device treatments effective and safe.
  • Information from your standard medical care is used, nothing extra is required.
  • The findings will help doctors better predict outcomes for patients with heart devices.
  • It helps ensure quality care for various heart rhythm and heart failure conditions.

Who may be eligible?

To be included in this study, patients generally need to be between 18 and 80 years old. Doctors will gather some of your existing medical information, which includes your medical history before the device was implanted, results from heart tests like ECGs and ultrasound scans of your heart, and blood test results that check things like your kidney and liver function.

You would not be able to join the study if you haven't given your written permission to share your information. This is to make sure everyone involved in the study understands and agrees to how their health details will be used.

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.

  1. Are you between 18 and 80 years old?
  2. Have you had a heart device implanted, or are you going to?
  3. Are your medical records available for doctors to review?
  4. Are you happy to give written permission for your health information to be used for the study?
Answer every question to see your result.

What does participation involve?

If you are part of this study, you won't need to do anything extra. This isn't a trial where you receive a new or experimental treatment. Instead, the study simply collects information from your existing medical records if you've had a heart device implanted. This includes details from your routine hospital visits concerning your health before the procedure, results from your standard heart tests, and information about the device implantation itself. Researchers will also track how you're feeling and how the device is working over time, using your regular follow-up appointments. There are no additional appointments, tests, or medications involved; it's all based on information already being collected as part of your usual care.

Potential risks and benefits

Participating in this study involves very minimal risk, as it mainly uses information from your medical records and doesn't require any extra procedures or changes to your care. The potential benefit is that the information gathered will help doctors learn more about how well heart devices work and how to improve care for future patients with similar conditions. You always have the right to withdraw your consent for your data to be used in the study at any time, without affecting your medical care.

Locations (1)

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine
    Verified postcode
    Düsseldorf, Germany· Recruiting

Common questions

What kind of heart problems is this study looking at?

This study is interested in conditions like a very slow heartbeat (bradycardia), a very fast heartbeat (tachycardia), and conditions that can lead to sudden heart problems.

What are heart devices?

Heart devices are small electronic tools, like pacemakers, that are placed inside your body to help your heart beat correctly or to monitor its activity.

Will I get a new treatment if I join this study?

No, this study only collects information about standard heart device implantations. You won't receive any new or experimental treatments just by joining.

How long will my information be used?

The study is collecting data from patients who had devices implanted between 2011 and 2019.

Is my personal information kept private?

Yes, all patient information collected for research studies is handled with strict privacy and confidentiality.

How to find out more

Hisaki Makimoto, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Registry of Device Implantation…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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