RESPOND Protocol Number: TP6461
Research type
Research Study
Full title
RESPOND: Repositionable Lotus Valve System – Post Market Evaluation of Real World Clinical Outcomes
IRAS ID
147377
Contact name
Daniel Blackman
Contact email
Sponsor organisation
Boston Scientific
Clinicaltrials.gov Identifier
Research summary
Study Design:
A prospective, open label, single arm, multi-center, observational post
market study.
Objective of the study is to collect real world clinical and device performance outcomes data with
the Lotus™ Valve System used in routine clinical practice for the
treatment of severe calcific aortic stenosis.
The Lotus Valve System is indicated to improve aortic valve function for
symptomatic subjects with severe calcific aortic stenosis (aortic valve
area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for
standard surgical valve replacement.
The device is commercially available.Study Population: All subjects who are candidates for Transcatheter Aortic Valve
Implantation (TAVI), signed the Informed Consent Form (ICF) and are
selected to receive a Lotus Valve will be evaluated for enrollment in this
study
Primary Endpoint: All-cause mortality at 30 days and 1 year after the implant procedure. All cause mortality at 30 days will be compared to a pre-specified performance goal.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/0086
Date of REC Opinion
15 Apr 2014
REC opinion
Further Information Favourable Opinion