Active not recruitingOBSERVATIONAL

Prospective and Non-randomized Registry of CardioCel 3D

This study, called the CardioCel 3D Registry, is collecting real-world information about a medical product called CardioCel. It's designed for people with various heart and blood vessel conditions, such as holes in the heart, problems with heart valves, or damaged blood vessels. Doctors are using CardioCel as part of their usual care. The purpose of this study is to see how well CardioCel works and if it's safe for patients over time. Researchers will be gathering details from at least 200 patients across several European hospitals. They will keep track of each patient's progress for two years after their CardioCel implant. This helps ensure that new versions and uses of CardioCel are safe and effective for patients.

At a glance

Status

Active not recruiting

Sponsor

LeMaitre Vascular

Enrolment target

200

Start

28 Aug 2020

Estimated completion

01 Mar 2026

Intracardiac and Septal Defects Valve and Anulus Repair Great Vessel Reconstruction Peripheral Vessel Reconstruction Suture Line Buttressing

What is this study about?

Imagine a special patch or material used by doctors to help fix problems with your heart or blood vessels. This study is all about one of those materials called CardioCel. Doctors use CardioCel for a few different reasons, like repairing holes inside the heart, fixing parts of heart valves, or rebuilding damaged arteries and veins elsewhere in the body. They also use it to strengthen stitches during surgery.

This isn't a study where doctors are trying out a brand new treatment on people for the first time. Instead, CardioCel is already an approved product that doctors are using as part of their standard care. The main goal of this 'registry' study is to simply watch and learn from how CardioCel performs in real patients outside of a strict clinical trial setting. Researchers want to make sure it continues to be safe and works well for people who need it.

To do this, many hospitals across Europe will be taking part. They will keep track of information from at least 200 patients who receive CardioCel. For each patient, the researchers will collect details about their health and how they are doing for two years after the CardioCel material is implanted. This helps show if CardioCel is a good and reliable option for people with these conditions, especially as new types and uses of CardioCel are developed.

Key takeaways

This study is collecting information on the safety and performance of CardioCel in real patients.
CardioCel is used for various heart and blood vessel conditions, like fixing holes or repairing valves.
Participation involves sharing your routine medical data for two years after receiving CardioCel.
You will receive standard medical care; no extra treatments or visits are required by the study itself.
The study helps improve understanding of CardioCel for future patient care.
You can withdraw from the study at any time without impacting your medical treatment.

Who may be eligible?

Joining this study is quite straightforward because it's looking at how CardioCel is used in everyday medical practice. To be considered, you would first need to understand the study and agree to take part by signing a consent form.

After that, the main requirement is that your doctor has already decided that CardioCel is the right treatment option for your heart or blood vessel condition, based on the approved uses of the product. This means you are already a candidate for CardioCel as part of your normal medical care.

There aren't any special health conditions that would stop you from joining this study. If your doctor believes CardioCel is suitable for you, and you agree to join, then you would likely be eligible.

Quick self-check

Have I discussed CardioCel with my doctor as a treatment option?
Am I already a candidate for CardioCel implantation based on my doctor's assessment?
Am I willing to sign an informed consent form?
Am I comfortable with researchers gathering information from my regular medical appointments for two years?
Do I understand that this study does not involve new or experimental treatments that are different from my usual care?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your involvement is mostly about allowing the researchers to collect information about your health as part of your regular medical appointments. You won't have any extra visits just for the study, nor will you receive any different medication or treatments than what your doctor would normally prescribe.

The study will collect details about your surgery where CardioCel is implanted, and then researchers will follow your progress through your routine check-ups for two years after your implant. This means they will look at things like scans, test results, and notes from your doctor's visits that are already part of your standard care. They might also ask your surgeon for their opinion on how easy CardioCel was to use during the operation. The total duration of your participation, from implant until the last follow-up, will be two years.

Potential risks and benefits

The main benefit of taking part in this study is helping doctors and researchers understand more about how CardioCel works in real-world situations, which can improve care for future patients. Since CardioCel is already an approved treatment and you'd be receiving it as part of your standard care, you wouldn't be undergoing any procedures or treatments specifically for the study that carry new risks. Any potential risks would be those usually associated with your medical condition and the implantation of CardioCel itself, which your doctor should discuss thoroughly with you. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (6)

Heart Center Leipzig
Leipzig, Germany
Policlinico San Donato
San Donato Milanese, Italy
A.O.U. Città della Salute e della Scienza
Turin, Italy
Hospital Universitario "Doce de Octubre"
Madrid, Spain
Bristol Children's Hospital and the Heart Institute
Bristol, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom

Common questions

What is CardioCel?

CardioCel is a special medical material used by doctors to help repair problems with hearts and blood vessels, like holes in the heart or damaged arteries.

Why is this study being done?

This study wants to learn more about how well CardioCel works and if it's safe for patients in everyday use, especially for new types and uses of the product.

Will I get special treatment in this study?

No, you will receive the same medical care and treatment, including CardioCel, that your doctor would normally recommend for your condition.

How long will I be involved in the study?

Researchers will follow your health and progress for two years after your CardioCel implant, using information from your regular doctor's visits.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive from your doctors.