Active not recruitingNAINTERVENTIONAL

Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality

This study is looking at the best way to treat a serious heart condition called aortic valve stenosis, where the main valve in your heart becomes narrowed. Doctors can fix this in two main ways: TAVI, which is a less invasive 'keyhole' procedure, or SAVR, which is traditional open-heart surgery. This trial is for patients aged 65-85 with severe aortic stenosis who are considered to have a low to medium risk for surgery. Participants will be randomly chosen to receive either TAVI or SAVR. The main goal is to find out if TAVI is just as safe and works just as well as SAVR in preventing serious problems like death or stroke after one and five years. This research is important because it could help doctors decide which treatment is best for these patients in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

1,414

Start

10 May 2017

Estimated completion

01 Jan 2028

Aortic Valve Stenosis

What is this study about?

Imagine the main exit door from your heart, called the aortic valve, becomes stiff and narrow, making it harder for blood to leave your heart to go to the rest of your body. This condition is called severe aortic valve stenosis and it can make you feel tired, breathless, or have chest pain.

Doctors have two main ways to fix this: one is called TAVI (Transcatheter Aortic Valve Implantation), which is a modern 'keyhole' procedure where a new valve is put in using a thin tube, often through a blood vessel in your leg. The other is SAVR (Surgical Aortic Valve Replacement), which is traditional open-heart surgery where the chest is opened, and the old valve is replaced.

This study, called DEDICATE, wants to compare these two treatments directly. Although TAVI has become very good, especially for people who are older or have other health issues, doctors want to be absolutely sure it's just as good and safe as SAVR for people who are considered to have a low to medium risk for surgery. By joining this study, you could help doctors understand which treatment is best for patients like you in the long term, potentially improving care for many others.

Key takeaways

Compares two heart valve treatments: TAVI (keyhole) vs. SAVR (open surgery).
For people aged 65-85 with severe aortic valve narrowing.
Specifically for those with low to medium risk for surgery.
Aims to see if TAVI is as safe and effective as SAVR long-term.
Participation involves random assignment to one treatment.
Requires follow-up appointments for up to five years.

Who may be eligible?

To be considered for this study, your heart’s main exit valve (aortic valve) must be severely narrowed, and this must be causing you symptoms like breathlessness, chest pain, or fainting. Both you and your medical team must agree that both the keyhole procedure (TAVI) and open-heart surgery (SAVR) are suitable and safe options for you.

Your doctors will also need to confirm that you are generally healthy enough for either surgery, meaning you are at a low to medium risk for complications during these procedures. This assessment will be done by a team of heart specialists, who will look at your overall health and any other medical conditions you might have. Also, the doctors must be able to perform the TAVI procedure successfully, usually through a blood vessel in your leg. If this isn't possible, other ways to do it might be considered.

Finally, to be eligible, you must be between 65 and 85 years old. The study is open to both men and women; if you are a woman, you must have gone through menopause (no periods for at least 12 months, not due to other medical reasons). You must also be able to understand the study information and be willing to sign a consent form to participate and attend all required follow-up appointments.

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.

Do you have severe narrowing of your aortic heart valve?
Do you experience symptoms like breathlessness, chest pain, or feeling faint?
Are you between 65 and 85 years old?
Has your heart team said both TAVI and SAVR are suitable for you?
Are you able to agree to attend all follow-up appointments for five years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full medical check-up to make sure you're suitable. Once confirmed, you would be randomly assigned to receive either the TAVI procedure (keyhole surgery) or SAVR (open-heart surgery). This is like flipping a coin – you won't get to choose which treatment you receive as part of the study.

After your procedure, your health would be carefully monitored. You would have regular check-ups with the study team to see how you are recovering and how well the new valve is working. These check-ups would happen at specific times, including one year and five years after your procedure. The study team would let you know exactly what is involved in these follow-up visits, as you'd need to agree to attend all of them to be part of the trial. The total duration of your participation in the study, including all follow-ups, would be five years.

Potential risks and benefits

Taking part in this study means you would receive one of two established treatments for your heart condition. A potential benefit is that you would be closely monitored by a team of specialists for five years. The treatments themselves carry certain risks, as with any medical procedure, including the risk of complications from surgery or the TAVI procedure. You will receive detailed information about the specific risks of both TAVI and SAVR from your doctors. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (43)

Universitäres Herz- und Gefäßzentrum Hamburg (UHZ)
Verified postcode
Hamburg, Germany
Uniklinik Rheinisch-Westfälische Technische Hochschule Aachen
Verified postcode
Aachen, Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Verified postcode
Bad Krozingen, Germany
Kerckhoff-Klinik Bad Nauheim
Verified postcode
Bad Nauheim, Germany
Herz- und Gefässklinik Bad Neustadt/Saale
Verified postcode
Bad Neustadt an der Saale, Germany
Herz- und Diabeteszentrum NRW Bad Oeynhausen
Verified postcode
Bad Oeynhausen, Germany
Charité Universitätsmedizin Berlin (Campus Benjamin-Franklin)
Verified postcode
Berlin, Germany
Charité Universitätsmedizin Berlin (Campus Mitte)
Verified postcode
Berlin, Germany
Charité Universitätsmedizin Berlin (Campus Virchow)
Verified postcode
Berlin, Germany
Deutsches Herzzentrum Berlin
Verified postcode
Berlin, Germany
Vivantes Friedrichshain
Verified postcode
Berlin, Germany
Vivantes Humboldt Kliniken
Verified postcode
Berlin, Germany

Common questions

What is aortic valve stenosis?

It's a condition where the main valve in your heart that lets blood out to your body becomes narrowed and stiff, making it harder for your heart to pump blood effectively.

What's the difference between TAVI and SAVR?

TAVI is a 'keyhole' procedure where a new valve is inserted through a small opening, often in your leg. SAVR is traditional open-heart surgery where your chest is opened to replace the valve.

Why is this study important?

It helps doctors understand which treatment, TAVI or SAVR, is best for people with severe aortic narrowing who are at low to medium risk for surgery, helping to improve future care.

Will I get to choose my treatment?

No, in this study, you would be randomly assigned to either TAVI or SAVR. This helps ensure fair and unbiased comparison between the two treatments.

How long will I be in the study?

If you join, you would be part of the study for five years, attending regular check-ups after your procedure.