VANTAGE Clinical Trial
Research type
Research Study
Full title
Evaluation of TAVR using the NAVITOR valve in a Global Investigation (VANTAGE Clinical Trial)
IRAS ID
293497
Contact name
Rebecca Malpass
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 0 months, 1 days
Research summary
The purpose of this study is to evaluate the safety and effectiveness of the Navitor valve system in an intermediate and low surgical risk patient population in treating patients with symptomatic, severe native aortic stenosis or valve disease. The study is intended to contribute to CE marking and other regulatory pre-market submissions.
Patients will be invited to receive the pre-CE marked device, Navitor valve, if they are indicated for a valve and meet the eligibility criteria in the protocol. The procedure is standard care. Participants will be followed up at Implant, discharge, 30-day visit, 12 months and then every year for 10 years or until the study is finished. Participants will complete questionnaires. Medications information will be collected. Stroke scale will be recorded, 6-minute walk test will be performed. Quality of life questionnaire will be administered. Blood sampling/testing will take place (standard care bloods).
A maximum of 590 patients worldwide will be enrolled in the VANTAGE clinical trial at up to 40 centres, in Australia and Europe.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0054
Date of REC Opinion
7 Jun 2021
REC opinion
Further Information Favourable Opinion