The EMPOWER Trial
Research type
Research Study
Full title
Assessment of the Carillon Mitral Contour System® in Treating Heart Failure with Functional Mitral Regurgitation
IRAS ID
346899
Contact name
Klaus Witte
Contact email
Sponsor organisation
Cardiac Dimensions, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 1 days
Research summary
Heart failure is a condition of breathlessness and fatigue due to changes in the heart's pumping function. These changes commonly include dilation (widening) of the main pumping chambers and a leak on the main non-return valve: the mitral valve.
This study aims to determine whether a device placed in the vein of the heart that can reduce dilation of the heart and the leakiness of the mitral valve can improve patient-orientated outcomes in people who have symptoms of heart failure due to reduced heart pumping function despite optimal tablet therapy.
Potential participants, approached by their usual care team will undergo a series of tests at an initial (baseline) visit and will come into hospital either on the morning of the procedure or the night before. They will undergo an coronary angiogram to look at the heart arteries, and via the vein in the neck, a catheter will be placed into the vein of the heart. At this point, the participant will be randomly allocated into either the treatment arm or the standard care arm. Neither the participant nor the assessor will know whether the device has been implanted. If allocated 'treatment', a device will be chosen around 4cm shorter than the vein of the heart and will be placed under tension to shorten this vein and thereby reduce the dimensions of the mitral valve ring. The procedure takes less than 45 minutes from start to finish, and participants will be monitored overnight on the day-case cardiology unit.
Participants will be discharged the following day and will be followed up by the blinded assessor six monthly for two years and then annually for a further three years.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0209
Date of REC Opinion
5 Dec 2024
REC opinion
Further Information Favourable Opinion