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
SUMMARY OF STUDY
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.
SUMMARY OF RESEARCH
A total of 505 patients were randomly allocated to one of two possible treatment groups: • 250 patients were assigned to the group that received the medical device “MitraClip” and heart failure medication according to normal clinical practice. • 255 patients were assigned to a group that was treated with heart failure medication according to normal clinical practice without MitraClip. CONCLUSIONS Among patients with heart failure with moderate to severe mitral heart valve deficiency who received medical therapy, the addition of mitral heart valve repair by MitraClip led to a lower rate of hospitalizations for heart failure or heart related death at 24 months and better health status at 12 months compared to medical therapy alone. The study was published in The New England Journal of Medcine as: Anker SD et al. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation. N Engl J Med 2024 Aug 31; [e-pub]. (https://doi.org/10.1056/NEJMoa2314328)
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