Active not recruitingNAINTERVENTIONAL

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

This study investigates a new treatment approach for people with heart failure caused by a condition called moderate aortic valve stenosis. This is when the main valve leaving your heart (aortic valve) is moderately narrowed, making your heart work harder. The study compares a minimally invasive procedure called Transcatheter Aortic Valve Replacement (TAVR) – which involves replacing the valve through a small tube inserted into a blood vessel in your leg – with the best possible standard treatments for heart failure. Researchers want to find out if TAVR is safe and effective in helping your heart work better and improving your overall health. This could be a new option for patients with this specific type of heart problem.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cardiovascular Research Foundation, New York

Enrolment target

178

Start

01 Sep 2016

Estimated completion

01 Feb 2025

Aortic Valve Stenosis

What is this study about?

When you have heart failure, your heart struggles to pump enough blood around your body. One potential cause of heart failure is a problem with your heart's valves. This study focuses on a condition called 'aortic valve stenosis,' where the aortic valve – the main valve that lets blood leave your heart – becomes narrowed. When this happens, your heart has to work much harder to pump blood, which can lead to heart failure symptoms like shortness of breath and tiredness. Normally, if the narrowing is severe, doctors might recommend replacing the valve.

This study is looking at people who have moderate aortic valve stenosis, meaning the narrowing isn't as severe, but it's still affecting their heart function and causing heart failure symptoms. The researchers want to see if replacing this moderately narrowed valve using a technique called TAVR (Transcatheter Aortic Valve Replacement) can help to improve their heart failure. TAVR is a less invasive procedure than traditional open-heart surgery, as the new valve is delivered through a small tube inserted into a blood vessel, usually in your leg.

The aim of the study is to compare TAVR with the usual, best possible treatments for heart failure, which typically involve a combination of medications and lifestyle changes. By comparing these two approaches, the study hopes to find out if TAVR is a safe and effective way to 'unload' or reduce the strain on the heart, potentially leading to better health for people with moderate aortic valve stenosis and heart failure. This could open doors to new treatment options for many patients.

Key takeaways

This study evaluates TAVR for heart failure due to moderate aortic valve narrowing.
It compares the TAVR procedure to standard heart failure medications.
The goal is to see if TAVR can help ease the strain on your heart.
Participation involves assessments and follow-up to check your heart health.
You have heart failure symptoms and a moderately narrowed aortic valve to be eligible.

Who may be eligible?

To join this study, you need to be at least 18 years old and have heart failure that's causing noticeable symptoms in your daily life, even if you're already receiving standard heart failure treatments. You should have been on a stable heart failure treatment plan for at least a month before joining. Your heart's main pumping chamber (left ventricle) should also be working less efficiently than usual.

Crucially, you must have 'moderate aortic valve stenosis.' This means the valve that lets blood leave your heart is narrowed, but not severely. Doctors will confirm this using a special heart scan called an echocardiogram. The study has specific measurements for this narrowing, which your doctors will check carefully. Sometimes, if the initial scan isn't clear, another scan called a 'dobutamine stress echo' might be used to confirm your eligibility.

Essentially, the study is looking for adults with heart failure symptoms and a specific level of narrowing in their aortic valve, who are already on appropriate heart failure medications. Other general health factors will also be assessed to make sure it's safe for you to participate.

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?
Do you have heart failure symptoms that affect your daily life?
Are you currently on stable medication for your heart failure?
Has a doctor told you that you have 'moderate' narrowing of your aortic valve?
Is the main pumping chamber of your heart (left ventricle) not working as well as it should?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll either receive the TAVR procedure or continue with your optimal heart failure medication. The TAVR procedure itself involves a hospital stay for the valve replacement. Both groups will have regular check-ups and tests, including heart scans (echocardiograms) and blood tests, to monitor your heart health and how you're feeling. You'll also have clinic visits with the study team. The total duration of your participation, including follow-up appointments, will be clearly explained to you by the study doctor. This will involve scheduled visits over a period of time to track your progress and any changes in your health.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your heart function and quality of life if the TAVR procedure proves effective for moderate aortic stenosis. However, like any medical procedure or extensive medication regimen, there are potential risks involved. The TAVR procedure carries risks such as bleeding, infection, and complications related to the heart or blood vessels, though these are rare. There are also risks and side effects associated with different heart failure medications. You will be fully informed about all potential risks and benefits before making any decision. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (51)

Chandler Regional Medical Center
Verified postcode
Chandler, United States
UCSD/Sulpizio Cardiovascular Center
Verified postcode
La Jolla, United States
University of Southern California - Los Angeles
Verified postcode
Los Angeles, United States
UCLA Medical Center
Verified postcode
Los Angeles, United States
St. Joseph Hospital
Verified postcode
Orange, United States
UCSF
Verified postcode
San Francisco, United States
Medical Center of the Rockies
Verified postcode
Loveland, United States
Yale University
Verified postcode
New Haven, United States
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States
University of Miami
Verified postcode
Miami, United States
Cleveland Clinic Florida
Verified postcode
Weston, United States
Advocate Christ Hospital
Verified postcode
Chicago, United States

Common questions

What is TAVR?

TAVR (Transcatheter Aortic Valve Replacement) is a procedure where a new heart valve is put into place through a small tube, usually inserted into an artery in your leg, without the need for open-heart surgery.

What is 'moderate aortic valve stenosis'?

This is when the main valve that lets blood leave your heart is narrowed, but not severely. This narrowing makes your heart work harder and can cause symptoms of heart failure.

Why is this study being done?

This study aims to see if replacing a moderately narrowed aortic valve with TAVR can help improve heart failure symptoms more effectively than just using standard heart failure medications.

Will I still take my heart failure medication if I have TAVR?

Yes, regardless of whether you have TAVR or not, you will continue to receive the best possible medical treatment for your heart failure as guided by your doctors.

What is an 'optimal heart failure therapy'?

This refers to the best standard medications and treatments available for managing your heart failure, as recommended by medical guidelines and tailored to your specific needs.