CARILLON
Research type
Research Study
Full title
Assessment of the CARILLON® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated with Heart Failure
IRAS ID
233399
Contact name
Aidan Doherty
Contact email
Sponsor organisation
Cardiac Dimensions Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 31 days
Research summary
“Functional mitral regurgitation” occurs when the mitral valve becomes dilated (larger) and does not close all the way. This happens because the left ventricle (the chamber of the heart responsible for pushing blood out to the body systems) has become larger, so that blood leaks backwards (into the left atrium and lungs) with each heartbeat. As a result, the heart is unable to pump the blood effectively and over time, the problem gets worse and patients experience symptoms of shortness of breath, fatigue (constantly tired), and/or difficulty concentrating. This is called “heart failure.”
This study is sponsored by Cardiac Dimensions Inc., based in the USA. The study device is called the CARILLON Mitral Contour System®. It is CE marked for the treatment of functional mitral regurgitation. The CE marking certifies that this medical device has met the European Union (EU) consumer safety requirements and can be freely commercialised throughout the EU.
The purpose of this clinical study is to evaluate the safety and efficacy of the CARILLON Mitral Contour System in people who have functional mitral regurgitation from heart failure. The CARILLON Mitral Contour System is used during a non-surgical (or minimally invasive) procedure to repair the mitral valve so that the mitral valve no longer leaks (regurgitation), or leaks less. The CARILLON implant is a device that is permanently implanted in the heart.
Patients that agree to participate will be involved for approximately 5 years. 360 patients will be enrolled in the study at up to 50 hospitals across Europe, North America and Australia. Patients will be randomly assigned to one of two groups – one group will receive the CARILLON implant and the other will not. About 67% of patients will be assigned to the group receiving the implant and 33% of patients will be assigned to the group that does not receive the implant. This will allow the treatment of the heart failure with and without the CARILLON implant to be compared.
REC name
West of Scotland REC 4
REC reference
17/WS/0227
Date of REC Opinion
5 Feb 2018
REC opinion
Further Information Unfavourable Opinion