RecruitingOBSERVATIONAL

The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)

This study is gathering information on a special type of heart device called an S-ICD, which is placed under the skin to help prevent sudden cardiac death. Unlike older devices, it doesn't need wires going into the heart itself. Doctors want to see how these devices perform in everyday situations, outside of strict research settings. They're looking at things like whether it causes fewer problems during the operation, how effective it is at stopping dangerous heart rhythms, and if there are any issues like getting shocks when they're not needed. The study also aims to understand how it works in different groups of people, including younger and older patients, and those with different heart conditions.

At a glance

Status

Recruiting

Sponsor

University of Luebeck

Enrolment target

4,000

Start

01 Jul 2022

Estimated completion

30 Sep 2025

Sudden Cardiac Death

What is this study about?

This study, called the International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSI), is all about understanding a modern heart device called an S-ICD. This device is a type of pacemaker that can recognise if your heart rhythm becomes dangerously fast and deliver an electrical shock to bring it back to normal. This helps prevent sudden cardiac death.

Unlike traditional devices that have wires going into your heart, the S-ICD sits entirely under your skin, which can make the operation safer and lead to fewer complications like infections or punctures to the lung. Since 2009, more and more people have been getting these devices, and doctors want to gather lots of information on how they perform in the real world. This means looking at patients in various hospitals and clinics, not just in a controlled research setting.

The main goal is to see how patients get on after having an S-ICD fitted. Researchers are particularly interested in finding out if there are fewer problems during the operation, whether the device gives shocks when they're not actually needed, and how effective it is in different types of patients, including teenagers and older adults, who might not have been studied much before. Understanding these things helps doctors make the best decisions for people needing this important heart treatment.

Key takeaways

Study focused on an implanted heart device called an S-ICD.
Aims to understand how S-ICDs work in real-life patients.
Primarily gathers information from existing medical records.
Helps doctors improve future care for sudden cardiac death.
Open to adults aged 18-99 with an S-ICD.
No new treatments or extra appointments required for participants.

Who may be eligible?

To be considered for this study, you would need to have already had an S-ICD device fitted. This study isn't about deciding if you should get one, but rather about collecting information from those who already have it.

After your S-ICD was put in, you must have been monitored for at least one month. This monitoring could have been through follow-up appointments at the clinic or remotely, meaning your device sent information to your doctors from home.

There are no specific reasons that would automatically exclude you from taking part, as long as you meet the points above. The study is open to both men and women aged between 18 and 99 years old.

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 18 years old or older?
Are you younger than 100 years old?
Have you already had an S-ICD device implanted?
Has it been at least one month since your S-ICD was put in?
Have you had at least one check-up (in-person or remote) since your S-ICD was implanted?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it largely involves allowing researchers to collect information about your existing S-ICD device and your health. Since this is a 'registry' (a way of collecting information over time), you don't need to have extra hospital visits or take new medications specifically for the study. Instead, the researchers will gather data from your routine follow-up appointments and records related to your S-ICD. This includes details about how your device was implanted, any complications you might have had, and how well the device has been working since it was put in. The study wants to follow patients for at least one month after their S-ICD is fitted, but longer-term information from your regular check-ups will also be valuable.

Potential risks and benefits

Taking part in this study generally carries very low risk, as it mainly involves collecting information from your existing medical records and routine check-ups. You won't be undergoing new procedures or taking study medications. The primary benefit is that the information gathered from you, along with many other patients, will help doctors better understand the S-ICD, identify ways to improve its use, and make better decisions for future patients. This helps advance medical knowledge for everyone at risk of sudden cardiac death. You are always free to withdraw your consent to have your data included in the study at any time without affecting your medical care.

Locations (1)

Clinic for Rhythmology
Verified postcode
Lübeck, Germany· Recruiting

Common questions

What is an S-ICD?

It's a special type of pacemaker placed under your skin that can deliver an electrical shock to correct a dangerous fast heart rhythm, helping to prevent sudden cardiac death.

How is it different from other pacemakers?

Unlike traditional pacemakers, the S-ICD sits completely under the skin and doesn't have wires going into your heart, which can reduce certain complications.

Will I have extra doctor appointments if I join?

No, this study mainly collects information from your regular medical appointments and records; you won't need extra visits just for the study.

Who can take part in this study?

Anyone aged between 18 and 99 who has already had an S-ICD fitted and has had at least one month of follow-up care.

Why is this study important?

It helps doctors learn more about how S-ICDs work in real patients, which can improve care for people at risk of sudden cardiac death in the future.

How to find out more

Julia Vogler, Dr.

julia.vogler@uksh.de +49 451 500 Official trial record

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