FlexNav EU CE Mark Study
Research type
Research Study
Full title
Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients with Symptomatic Severe Aortic Stenosis
IRAS ID
256075
Contact name
Ganesh Manoharan
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-18-10-025924, EUDAMED Number
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
The purpose of this research study is to collect safety data on the new (next-generation) FlexNav delivery system, which is used to implant the Portico valve inside a diseased heart valve.
The FlexNav delivery system has been modified from its original (first-generation) design to make the insertion size of the system smaller so it can manoeuvre more easily through narrow arteries, improving the doctor’s ability to more precisely position the Portico valve in the diseased heart valve and be easier to use.
It is possible these new design modifications may reduce some of the known risks associated with transcatheter aortic valve implantation (TAVI) procedures- specifically risk of vascular injuries and bleeding.
The Study will enroll approximately 200 subjects at up to eight sites in Europe. Patient involvement will last approximately 12 months from the time of the implant procedure. At the end of the study, the patient will continue to be followed in accordance with local practice.
The study will involve seven visits:
• Screening
• Baseline
• Implant
• Discharge
• 30-day follow-up
• 6-month follow-up
• 12-month follow-upREC name
HSC REC A
REC reference
18/NI/0234
Date of REC Opinion
11 Feb 2019
REC opinion
Further Information Favourable Opinion