Active not recruitingNAINTERVENTIONAL

2019-06 TRISCEND Study

This is a study called TRISCEND, looking at a new way to treat a leaky heart valve, specifically the tricuspid valve. If your tricuspid valve isn’t closing properly, it can cause problems and make you feel unwell, even with medication. This study is testing a new device called the Edwards EVOQUE Tricuspid Valve Replacement System. Doctors want to understand how safe and effective this new treatment is for people who have tried other options but still have symptoms. It’s for adults whose heart doesn't pump blood as efficiently as it should because of this leaky valve.

At a glance

Status

Active not recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

228

Start

06 May 2020

Estimated completion

31 Jan 2029

Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Results

Results from this study

Posted January 2025

Results have been published for this study.

Primary outcome

Composite Major Adverse Events (MAEs)

Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.

Full results on the registry

What is this study about?

This study is investigating a new treatment for a heart condition called tricuspid valve regurgitation. Put simply, this means one of the valves in your heart, called the tricuspid valve, isn't closing properly. Instead of blood flowing forwards, some leaks backwards, which can make your heart work harder and cause symptoms like feeling tired or breathless.

The TRISCEND study is looking at a new device called the Edwards EVOQUE Tricuspid Valve Replacement System. This system aims to replace the leaky tricuspid valve without needing open-heart surgery. Instead, it's inserted using a thin tube called a catheter, usually through a blood vessel, which is less invasive. Doctors want to see how well this new device works and how safe it is for patients.

The main goal is to help people who are still experiencing symptoms from their leaky tricuspid valve even though they are already taking medication for it. By replacing the faulty valve, doctors hope to improve heart function and reduce these uncomfortable symptoms, ultimately making patients feel better.

Key takeaways

This study evaluates a new non-surgical treatment for a leaky heart valve.
It's for people with a leaky tricuspid valve who still have symptoms despite medication.
The new device is called the Edwards EVOQUE Tricuspid Valve Replacement System.
The study aims to check how safe and well this new treatment works.
Participation involves careful assessment to see if it's right for you.

Who may be eligible?

To join this study, you would need to have a leaky tricuspid heart valve that is moderate or worse, and you must still be experiencing symptoms even after trying regular medications, or you've been in hospital before because of this valve problem.

Your heart care team at the hospital would then need to agree that this specific type of valve replacement, done using a catheter, is the right choice for you.

However, you wouldn't be able to join if there are reasons related to your heart's structure that make this procedure unsuitable, or if you need urgent surgery. You also can't be suffering from very severe heart failure that requires other special treatments, or already be involved in another medical study where the main results haven't been finalised.

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 a moderate or severe leaky tricuspid heart valve?
Are you still experiencing symptoms from this leaky valve, despite taking your medication?
Has your heart team at the hospital considered whether a transcatheter tricuspid valve replacement might be right for you?
Are you able to undergo a procedure that involves replacing a heart valve using a thin tube (catheter)?
Are you not currently involved in another medical study or needing urgent heart surgery?

Answer every question to see your result.

What does participation involve?

Information about what taking part involves has not been fully provided in the clinical trial summary. Generally, if you join a study like this, you would likely have several visits to the hospital for check-ups and tests both before and after the valve replacement procedure. These tests might include heart scans and blood tests to monitor your progress and how well the new valve is working. You would probably also have regular follow-up appointments over a period of time to make sure you are recovering well and that the device is performing as expected. The total duration of your participation, including these follow-up visits, would be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment that might improve your heart condition and reduce your symptoms, possibly before it's widely available. However, as with any medical procedure, there are potential risks, including those related to the procedure itself and how your body might react to the new device. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
Stanford University
Verified postcode
Stanford, United States
Emory University
Verified postcode
Atlanta, United States
Piedmont Heart Institute
Verified postcode
Atlanta, United States
Northwestern University
Verified postcode
Evanston, United States
Massachusetts General Hospital Boston
Verified postcode
Boston, United States
Brigham and Women's Hospital
Verified postcode
Boston, United States
Henry Ford Hospital
Verified postcode
Detroit, United States
Columbia University Irving Medical Center / NYPH
Verified postcode
New York, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
Oregon Health & Science University
Verified postcode
Portland, United States
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States

Common questions

What is the tricuspid valve?

It's one of the four valves in your heart. It makes sure blood flows in the right direction from one of the heart chambers to another.

What does 'regurgitation' mean for a heart valve?

It means the valve is leaky. Instead of closing tightly, some blood flows backwards through it, making your heart work harder.

What is a 'transcatheter' procedure?

It's a way to do surgery using a thin tube called a catheter, often through a blood vessel, instead of making a large cut. It's usually less invasive.

Why would someone need this treatment?

It's for people whose leaky tricuspid valve causes symptoms and isn't getting better even with medication.

Is this treatment guaranteed to work?

No medical treatment, especially a new one in a study, can be guaranteed to work. The purpose of this study is to find out how safe and effective it is.