The RESHAPE-HF Trial (MitraClip)
Research type
Research Study
Full title
A RANDOMIZED STUDY OF THE MITRACLIP DEVICE IN HEART FAILURE PATIENTS WITH CLINICALLY SIGNIFICANT FUNCTIONAL MITRAL REGURGITATION
IRAS ID
129375
Contact name
Michael Mullen
Contact email
Sponsor organisation
Abbott Vascular International BVBA
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to further study the safety and effectiveness of the MitraClip System in the treatment of mitral regurgitation in patients with chronic heart failure. The trial will also collect information on healthcare economics. Mitral regurgitation (MR) occurs when the two leaflets of mitral valve do not close properly causing blood to leak backward into the left atrium from the left ventricle when the heart beats. This causes the heart to pump more blood each time it beats to push the same amount of blood through the body. The type and severity of the patients MR has been categorized as clinically significant functional MR (FMR). Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs. This is a randomized trial, which means that subjects will be randomly assigned to one of the 2 different ways of treating their heart condition in this trial. They have a 50/50 chance of being assigned to either of two treatment options. The treatment options are:
Control Group (optimal standard of care therapy alone): in this group, they will continue to take their medicines (medical drug therapy) and any standard treatment for their heart condition, but they will not undergo the MitraClip implant procedure for the treatment of their FMR. They may become eligible to receive the MitraClip device after they have completed the 24-month follow-up visit or the last subject to join the trial has completed 12-month follow-up visit, whichever occurs first.
Device Group (MitraClip device plus optimal standard of care therapy): in this group, they will continue to take their medicines (medical drug therapy) and any standard treatment for their heart condition, and they will also undergo the MitraClip implant procedure. They may receive up to three MitraClip devices during the implant procedure.REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/0973
Date of REC Opinion
12 Jul 2013
REC opinion
Favourable Opinion