The MitraClip EXPAND Study
Research type
Research Study
Full title
The MitraClip EXPAND Study: A Contemporary, Prospective Study Evaluating Real-world Exprience of Performance and Safety for the Next Generation of MitraClip Devices.
IRAS ID
245394
Contact name
Robert Smith
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
The MitraClip EXPAND Study is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System (devices used in the study), to treat mitral regurgitation. Mitral Regurgitation occurs when the two leaflets of the mitral valve (small flap in the heart), do not close properly causing blood to leak backwards with each heartbeat. Since some of the blood leaks backwards, the heart must pump more blood with each beat to push the same amount of blood forward. The MitraClip system consists of a delivery catheter and an implantable clip that is designed to repair the mitral valve by clipping the two leaflets together. The study will enrol male and female subjects of 18 years + with symptomatic mitral regurgitation. The study visits will be Pre-Treatment (Baseline), Treatment (Procedure), Discharge, 30-day, 6 month (which can be a telephone visit) and 1 year. Up to 1,000 consented subjects with confirmation of no thrombus (blood clot) who have a MitraClip procedure attempted, will be included for analysis in the study. The study will be conducted at a maximum of 60 centres in the EU and the US. No site can enrol more than 10% of the study population, each participating UK site can only enrol 100 subjects maximum. The first 220 patients treated using the MitraClip XTR System will be included in the MitraClip XTR PMCF study, data collected will be used to fulfil regulatory requirement for post-market clinical follow up.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1475
Date of REC Opinion
15 Oct 2018
REC opinion
Further Information Favourable Opinion