MISSION 2015-05
Research type
Research Study
Full title
Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry
IRAS ID
195195
Contact name
Christophe Giot
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 18 days
Research summary
Aortic stenosis remains the most common cause of adult heart valve disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2—5 years from the onset of symptoms. Early surgery offers an option to improve clinical outcomes by decreasing cardiac deaths and improving symptoms.\n\nValve implants with biological material, offer several advantages over simply mechanical valve implants, the most important being freedom from the need for drugs and interventions designed to prevent potentially dangerous blood clots\n\nMinimally-invasive surgery should have less injury from the operation, other complications and adverse effects than an equivalent open surgery. Operative time is longer, but hospitalisation time is shorter. It causes less pain and scarring, speeds recovery, and reduces the incidence of post-surgical complications.\n\nThe EDWARDS INTUITY Elite System has been designed to facilitate minimally invasive surgery for the replacement of aortic valves. \n\nThis study will collect data from aortic valve replacement surgeries with EDWARDS INTUITY Elite Systems in a post-market setting. Data collected will include certain procedure times, clinical outcomes and variations in blood in the heart. \n\nOnce enrolled, subjects will attend hospital for surgery and during surgery will be assessed to confirm the patient is suitable for EDWARDS INTUITY Elite System. If the patient is not suitable they will receive a different valve system. Subjects will be treated by each hospitals standard of care. The subjects will be followed up for six months with a 30-day phone call and 6-month clinic visit to assess an adverse events and clinical outcomes. \n
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0871
Date of REC Opinion
23 Jun 2016
REC opinion
Further Information Favourable Opinion