MATTERHORN
Research type
Research Study
Full title
A multicenter, randomized, controlled study to assess mitral valve reconstruction for advanced insufficiency of functional or ischemic origin (MATTERHORN)
IRAS ID
242014
Contact name
Philip Andrew MacCarthy
Contact email
Sponsor organisation
University of Cologne, Dept. of Cardiology
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, days
Research summary
In this randomised, controlled, parallel group study, the efficacy and safety of interventional percutaneous mitral valve repair (PMVR) by means of the medical device "MitraClip" for patients with moderate-to-severe mitral regurgitation (MR) will be investigated as compared to surgical therapy (mitral valve surgery or mitral valve replacement; MVS).
MR is a common form of vavular heart disease caused by the mitral valve not closing properly, when the left ventricle contracts, thus blood can leak backwards into the left atrium. This may result in increased blood pressure in the left atrium leading to palpitations, increased pressure in the pulmonary veins and ultimately congestion in the lungs and heart failure. Despite optimal medical care MR is associated with increased mortality and hospitalization rates.
Traditionally, MVS has been the therapy of choice for patients with MR. More recently, PMVR has evolved as an important therapeutic option with widespread use. So far, PMVR has only been compared to MVS in a controlled, randomized clinical study in patients with primary MR; where PMVR has been shown to be less effective than surgery. However, there is no according data comparing the efficacy and safety of the two therapy options in patients with depressed left ventricular function and secondary MR, who are known to have a considerably higher perioperative risk.
Unlike in MVS, in PVMR the valve is accessed by means of a steerable delivery system via the femoral vein and the left atrium; then the MitraClip is secured to the leaflets of the mitral valve.
210 adult patients, clinically diagnosed with clinically significant MR of primiarily functional pathology will be enrolled. The intervention takes 2 – 6 hours per patient followed by a 12 months follow-up period. The study will be conducted at 4 sites in the UK and X sites in Austria. It is already ongoing at 18 sites in Germany.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
19/LO/0414
Date of REC Opinion
28 May 2019
REC opinion
Further Information Favourable Opinion