RESHAPE-HF2 v. 3.4 dated 15.03.2017
Research type
Research Study
Full title
RANDOMISED INVESTIGATION OF THE MITRACLIP DEVICE IN HEART FAILURE: 2ND TRIAL IN PATIENTS WITH CLINICALLY SIGNIFICANT FUNCTIONAL MITRAL REGURGITATION
IRAS ID
220456
Contact name
Anker Stefan
Contact email
Sponsor organisation
University of Gottingen
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 10 days
Research summary
Patients who have a heart muscle that does not pump as well as it should are said to have heart failure. The hearts of patients with heart failure are often enlarged. One of the detrimental effects of having a heart that is too large is that one of the heart valves, the mitral valve, sometimes becomes leaky. A new technique using a device called Mitraclip can make this valve less leaky by pinching or clipping the tips of the valve together. This device is inserted by passing a tube from the groin through the veins into the heart ie the procedure does not involve open heart surgery. In the current trial patients will be looked after as well as possible with half undergoing the new procedure and half remaining as they are.
REC name
West of Scotland REC 4
REC reference
17/WS/0187
Date of REC Opinion
13 Oct 2017
REC opinion
Further Information Favourable Opinion