RecruitingNAINTERVENTIONAL

Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

This research is focused on a procedure called valve-in-valve Transcatheter Aortic Valve Replacement (ViV-TAVR), which helps people whose artificial heart valves aren't working properly. After this procedure, it's important to check how well the new valve is performing. Doctors typically use an ultrasound scan, but sometimes the results from ultrasound can be different from another test where a small tube (catheter) is used to measure things directly inside the heart. This study aims to find out if using the catheter measurements to guide treatment leads to better results than just relying on ultrasound. By comparing these two methods, the researchers hope to improve how doctors confirm the success of ViV-TAVR and make sure patients get the most accurate assessment of their new valve's function.

At a glance

Status

Recruiting

Phase

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Enrolment target

310

Start

11 Jan 2023

Estimated completion

01 Sep 2029

Aortic Valve Stenosis Aortic Valve Regurgitation Prosthesis Failure

What is this study about?

When someone has a problem with an artificial heart valve that was put in during a previous operation, doctors can sometimes fit a new valve inside the old one without needing open-heart surgery. This procedure is called valve-in-valve Transcatheter Aortic Valve Replacement, or ViV-TAVR.

After a ViV-TAVR procedure, it's very important to check that the new valve is working correctly. Traditionally, doctors use an ultrasound scan of the heart (called an echocardiogram or echo) to do this. However, some studies have shown that the echo might sometimes suggest the valve isn't working as well as it actually is, potentially making it seem like there are more problems than there truly are.

This study wants to compare the echo with another method called cardiac catheterization. This involves gently threading a thin tube (catheter) into the heart to take very precise measurements. The aim is to see if using these catheter measurements to guide how we optimise the valve makes a difference. By doing this, we hope to find the best way to accurately assess how well the new heart valve is working after a ViV-TAVR, ensuring patients receive the right care and that problems are correctly identified.

Key takeaways

A study comparing two ways to check new heart valves after a 'valve-in-valve' procedure.
Aims to find the most accurate method to assess valve performance.
Involves patients with artificial heart valve problems.
Compares ultrasound checks with measurements from a small tube (catheter).
May help improve future care for patients having this procedure.

Who may be eligible?

This study is looking for adults aged 18 and over who have problems with their artificial heart valve (called a bioprosthetic valve) and whose doctors have decided that a valve-in-valve TAVR procedure is the right treatment for them. Your existing artificial valve must be a specific type and size (no larger than 25mm).

You wouldn't be able to join the study if your artificial valve is a very specific type that isn't suitable for this procedure, or if there's a high risk that the new valve could block an important blood vessel in your heart. Also, if for any reason you're unable to give your written permission to take part, you wouldn't be included.

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?
Has your heart team approved you for a 'valve-in-valve' procedure?
Do you have a specific type of artificial heart valve that needs replacing (a stented bioprosthetic valve 25mm or smaller)?
Have you been told you don't have a very high risk of complications with the procedure?
Can you provide written consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, and you meet all the criteria, you will be one of two groups. Both groups will have the ViV-TAVR procedure with a specific type of valve (SAPIEN 3 ULTRA). The difference is in how your doctors will check and then, if needed, adjust your new valve's performance. One group will have these checks guided by special ultrasound scans, while the other group will have them guided by measurements taken with a small tube (catheter) inserted into your heart. The total duration of your participation in the study would depend on standard follow-up for your procedure, with specific research assessments at the start and after your procedure.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this study doesn't offer a new treatment, it aims to find the most accurate way to check your new heart valve's performance, which could lead to better care for you and future patients. The risks involved are generally related to the standard medical procedures you would receive anyway, such as the ViV-TAVR itself and the assessment methods (ultrasound or catheterization), which your medical team will discuss with you. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (7)

University of California
Verified postcode
San Francisco, United States· Not yet recruiting
South Broward Hospital Disctrict D/B/A Memorial Healthcare System
Verified postcode
Hollywood, United States· Recruiting
William Beaumont Hospital
Verified postcode
Royal Oak, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
St-Joseph's Health INC
Verified postcode
Syracuse, United States· Not yet recruiting
The Christ Hospital Health Network
Verified postcode
Cincinnati, United States· Recruiting
IUCPQ
Verified postcode
Québec, Canada· Recruiting

Common questions

What is a 'valve-in-valve' procedure?

It's when a new heart valve is placed inside an artificial valve that isn't working well, without needing major open-heart surgery.

What is the study trying to find out?

It wants to compare two ways of checking how well a new heart valve is working after the 'valve-in-valve' procedure, to see which method is more accurate.

Will I get standard medical care if I join?

Yes, all participants will receive the standard 'valve-in-valve' procedure. The study is about how your new valve's performance is checked and optimised.

What is the difference between the two ways of checking the valve?

One way uses an ultrasound scan (like a picture from sound waves), and the other uses a small tube called a catheter to take direct measurements inside your heart.

Do I have to do anything differently if I participate?

You'll have your procedure as planned. The main difference will be how your new valve is assessed and potentially adjusted afterwards, depending on which group you're in.

How to find out more

Josep Rodés-Cabau, MD

josep.rodes@criucpq.ulaval.ca 418-656-8711 Official trial record

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