PORTICO NG Approval Study (Navitor Titan cohort only), CIP rev D
Research type
Research Study
Full title
Portico NG Approval Study - Evaluation of the Portico™ NG Transcatheter Aortic Valve in High and Extreme Risk Patients with Symptomatic Severe Aortic Stenosis
IRAS ID
314653
Contact name
Rebecca Malpass
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
PORTICO NG Study, CI/2019/0036
Duration of Study in the UK
5 years, 4 months, 30 days
Research summary
The purpose of this research study is to collect data on the Portico NG TAVI system (Portico NG Transcatheter Aortic Valve, FlexNav delivery system and Portico NG Loading System), which is used to treat heart valve disease, and to support commercial approval of the device.
This new application is being made at the request of the MHRA to obtain approval for the larger size heart valve to be included in this study (Navitor Titan- 35mm). The additional valve has been included in CIP revision D, both tracked change and clean versions have been included with this application.
REC name
HSC REC B
REC reference
22/NI/0086
Date of REC Opinion
30 Jun 2022
REC opinion
Further Information Favourable Opinion