Optimize PRO
Research type
Research Study
Full title
Optimize PRO TAVR Post Market Study
IRAS ID
291980
Contact name
Hanne Gonnissen
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure to replace a narrowed aortic valve that fails to open properly (aortic valve stenosis).
The objective of this study is to collect information on the Evolut™ PRO and Evolut™ PRO+ valve performance while following a specific, optimised, TAVR care pathway. Additionally, this study will also specify how post-TAVR conduction disturbances should be managed and evaluate whether a consistent approach reduces the variation currently seen in this area.The Optimize PRO study is a postmarket study therefore devices used in this study must be commercially approved in the geography they are used. Currently only the Evolut PRO System is commercially approved (CE marked) in the UK. The Evolut PRO+ System will only be used in the UK should it become commercially approved (CE marked).
Lay Results:
30-day all-cause mortality or all-stroke rate is 5.1% 30-day all-cause mortality rate of 0.8% 30-day all-stroke rate of 4.4% (disabling stroke rate of 1.7%) Global median length of stay was 2 days for attempted implant population New pacemaker implantation rate of 11.1% at 30 days for attempted implant population No moderate or severe total aortic regurgitation (AR) or PVL at discharge ≥ Mild AR at discharge: 23.8% Excellent post-procedure hemodynamics (mean gradient 8.3 mmHg, EOA 2.25 cm2).
Re-admission rate at 30-day was 9.1% with cardiovascular rehospitalization 5.7% for attempted implant populationREC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0022
Date of REC Opinion
30 Mar 2021
REC opinion
Further Information Favourable Opinion