RecruitingOBSERVATIONAL

Hydra Registry - UK

This study is investigating a new type of heart valve, called the Hydra valve, for people who have a condition called aortic stenosis. This is when the main valve leaving your heart becomes narrow, making your heart work harder. Doctors will fit the new valve using a special procedure called TAVI. We want to see how good the new valve is at helping people, how safe it is, and if it allows future treatments to the heart. We’ll follow patients for up to a year. We're also looking at a new device called Checkpoint Cardio. This is a small, portable monitor that checks your heart's electrical activity for three days after you leave the hospital, to see if it's a useful way to keep an eye on your heart health at home.

At a glance

Status

Recruiting

Sponsor

Sahajanand Medical Technologies Limited

Enrolment target

250

Start

11 Jul 2024

Estimated completion

01 Aug 2026

Aortic Valve Stenosis

What is this study about?

This study is about a new type of artificial heart valve system called the Hydra. It's designed for people who have a condition called aortic stenosis. This is a common heart problem, especially as people get older, where the main valve that lets blood out of your heart (the aortic valve) becomes stiff and narrow. This makes your heart work much harder to pump blood around your body.

The Hydra valve is put into place using a special procedure called TAVI (Transcatheter Aortic Valve Implantation). This is a less invasive way to replace the valve, usually done by guiding a new valve through a blood vessel, often in the leg, up to the heart. The main goals of this study are to see how well the Hydra valve works, how safe it is for patients, and if it makes future heart treatments easier, particularly if doctors need to access other heart blood vessels later on. We'll be keeping a close eye on patients for a year after their procedure.

Separately, the study is also testing a new portable heart monitor called the Checkpoint Cardio System. After leaving the hospital, some patients might wear this device for three days. It continuously records your heart's electrical activity (like an ECG) while you're at home. This helps doctors see if this device is a good way to monitor your heart after your valve procedure.

Key takeaways

This study evaluates a new heart valve called Hydra for people with severe aortic stenosis.
The Hydra valve is implanted using a TAVI procedure, which is less invasive than open-heart surgery.
The study will check how well the valve works and how safe it is for up to one year.
It also looks at a new portable heart monitor (Checkpoint Cardio) for use after leaving hospital.
Your medical team will follow your progress with appointments at about 6 weeks and 1 year.
Participation is voluntary, and you can withdraw at any time without impacting your regular care.

Who may be eligible?

To join this study, you would need to be 18 years old or older and have severe aortic stenosis. This means your heart valve is significantly narrowed. Your heart care team would need to agree that a TAVI procedure (where doctors replace your valve without open-heart surgery) is the right treatment for you.

There are certain reasons why you might not be able to take part. For example, if your doctors believe the TAVI procedure isn't suitable for you because of other health conditions, or if the arteries in your legs or other areas are too narrow to allow the procedure to happen safely. Also, if there are any specific issues with your heart's structure, significant calcium build-up, or if the Hydra valve itself isn't considered the best fit for you, you wouldn't be able to join.

It's really important that you understand what the study involves and are happy to agree to take part. If you don't feel comfortable giving your consent, or if you change your mind at any point, you can't be in the 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 18 years old or older?
Have you been diagnosed with severe aortic stenosis?
Has your heart team suggested that TAVI is a suitable treatment option for you?
Are you able to understand and willing to give your agreement to take part in the study?
Are you free from severe problems with your arteries that would prevent a TAVI procedure?
Has your doctor ensured the Hydra valve is a good fit for your specific heart condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo the TAVI procedure to have the Hydra heart valve implanted. After your procedure, doctors will immediately check if they can easily access your heart's own blood vessels (called coronary arteries) through special X-ray tests. This is only done for some patients, if it's considered necessary.

Some patients, if their medical team thinks it's appropriate, will also wear a small, portable heart monitor called the Checkpoint Cardio System for 72 hours (3 days) after they leave the hospital. This device will continuously record your heart's electrical activity.

You'll have follow-up appointments after you leave the hospital. These are usually scheduled around 45 days (about six weeks) and then again at 1 year after your procedure. These appointments are to check on your health and how well the new valve is working. The total duration of your participation in the study, including follow-up, will be about one year.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new type of heart valve that could improve your heart function and quality of life, alongside careful monitoring. However, as with any medical procedure, there are potential risks, including those associated with the TAVI procedure itself, such as bleeding, infection, or complications related to the valve. The devices being studied, including the Hydra valve and the Checkpoint Cardio monitor, also carry their own potential risks and benefits, which your medical team will discuss with you. You have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting
Royal Victoria Hospital
Verified postcode
Belfast, United Kingdom· Not yet recruiting
Royal Papworth
Verified postcode
Cambridge, United Kingdom· Not yet recruiting
Castle Hill Hull
Verified postcode
Cottingham, United Kingdom· Recruiting

Common questions

What is Aortic Stenosis?

It's a condition where the main valve letting blood out of your heart becomes narrow, making your heart work harder.

What is TAVI?

TAVI (Transcatheter Aortic Valve Implantation) is a way to replace your heart valve through a small cut, usually in your leg, rather than open-heart surgery.

What is the Hydra valve?

The Hydra Transcatheter Aortic Valve (THV) is a new type of artificial heart valve being studied to see how well it works and if it's safe.

What does the Checkpoint Cardio monitor do?

It's a small device that records your heart’s electrical activity (like an ECG) for three days after you go home, to see how your heart is doing.

How long will I be involved in the study?

Your involvement in the study will last for approximately one year after your heart valve procedure, including follow-up appointments.

How to find out more

Dr. Javaid Iqbal, MRCP, PhD

j.iqbal@sheffield.ac.uk 7788438471 Official trial record

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