Active not recruitingOBSERVATIONAL

REDUCER-I: An Observational Study of the Neovasc Reducer™ System

This study, called REDUCER-I, is looking into the long-term effects of a device called the Neovasc Reducer™ System. The Reducer is designed to help people who have chronic angina pectoris, which is ongoing chest pain that hasn't gotten better with standard medications or procedures. The study is split into three groups: one group of new patients, another group who were part of an earlier Reducer study (COSIRA), and a third group who received the Reducer as a normal treatment. Researchers want to understand how the device works over time for these different groups of patients, collecting information from up to 400 people across various hospitals and clinics.

At a glance

Status

Active not recruiting

Sponsor

Shockwave Medical, Inc.

Enrolment target

400

Start

01 Mar 2016

Estimated completion

01 Dec 2028

Angina Pectoris Angina Pectoris, Stable Chronic Stable Angina

What is this study about?

Imagine you have chest pain, called angina, which happens when your heart muscle isn't getting enough oxygen. For some people, this pain is ongoing and severe, even after trying different medicines or heart procedures like bypass surgery or stents. This is called 'refractory angina' and it can be really tough to live with.

This study is about a special device called the Neovasc Reducer™ System. It's a small, hourglass-shaped device that's placed into a vein on the surface of your heart, called the coronary sinus. The idea is that it helps improve blood flow to parts of the heart that aren't getting enough oxygen, which can hopefully reduce chest pain.

The REDUCER-I study is collecting information about how well this device works over a long period. They are looking at people who are receiving the Reducer for the first time, as well as those who had it put in during a previous study or as part of their regular treatment. The goal is to learn more about its long-term benefits and safety, helping doctors understand if it's a good option for people with this type of difficult-to-treat angina.

Key takeaways

This study is for people with severe, ongoing chest pain (angina).
It's looking at a device called the Reducer that aims to improve heart blood flow.
The study wants to learn about the Reducer's long-term effects.
It includes new patients and those who already have the device.
Participation involves regular check-ups and assessments.

Who may be eligible?

This study is looking for adults aged 18 and over who have chronic, ongoing chest pain (angina) that hasn't responded to other treatments. You might be considered if your doctor believes that traditional heart procedures like bypass surgery or stents aren't suitable or haven't worked for you.

There are a few key things they'll check. You'll need to show signs that parts of your heart muscle aren't getting enough blood flow when needed, and your heart's main pumping chamber (left ventricle) needs to be working reasonably well.

Some things would mean you can't join. For example, if you've recently had a heart attack, recent heart surgery or a stent, severe heart failure, or certain lung conditions. If you have a pacemaker in a specific heart vein or can't do certain exercise tests, you also wouldn't be able to participate.

Quick self-check

Are you 18 years old or older?
Do you have ongoing chest pain (angina) that hasn't cleared up with other treatments?
Has your doctor said that heart bypass surgery or stents aren't good options for you?
Do you not have active heart issues like a recent heart attack or severe heart failure?
Are you able to do some simple exercise tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll first need to read and sign a consent form, which explains everything in detail. You'll then have a series of appointments where doctors will check your health. This will involve regular visits to the hospital or clinic, which might include having tests to see how your heart is working, like exercise tests or a walking test, and possibly other scans or check-ups. The Reducer device may be implanted if you're in the new patient group. For those who already have the Reducer, the study will mainly involve follow-up assessments. The overall duration of your participation will depend on which group you're in, as some are collecting long-term information.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be an improvement in your debilitating chest pain, which could lead to a better quality of life if the Reducer works for you. All medical procedures carry risks; for the Reducer, these could include risks associated with any heart procedure, such as bleeding, infection, or issues related to placing the device. The study is designed to monitor participants closely. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (25)

University of Graz
Graz, Austria
ZNA Middelheim Hospital
Antwerp, Belgium
Zienkenhuis Oost-Limburg
Genk, Belgium
University Hospital of Brest
Brest, France
Institut Coeur Poumon
Lille, France
Kerckhoff Klinik
Bad Nauheim, Germany
Dresden University
Dresden, Germany
Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie
Essen, Germany
University Heart Center Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany
University Giessen
Giessen, Germany
University Heart Center Hamburg
Hamburg, Germany
San Raffaele Hospital
Milan, Italy

+13 more sites — see the official record for the full list.

Common questions

What is angina pectoris?

Angina pectoris is chest pain or discomfort that happens when your heart muscle doesn't get enough oxygen-rich blood. It often feels like a squeezing or pressure in your chest.

What is the Neovasc Reducer System?

It's a small device that is placed in a specific vein around the heart. It's designed to help improve blood flow to the heart muscle for people with severe, ongoing angina that hasn't responded to other treatments.

Why is this study being done?

This study wants to collect long-term information about how well the Reducer works in people with chronic angina, to better understand its benefits and safety over time.

Will I receive the Reducer in this study?

If you are a new patient joining the first group (Arm 1), the Reducer device might be implanted as part of the study. Other groups include people who already have the Reducer.

How long does the study last?

The study aims to collect long-term data, so participation could involve follow-up over an extended period. The exact length would be explained if you're eligible.