Portico NG Approval Study
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
269254
Contact name
Ganesh Manoharan
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 28 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 your heart valve disease, and to support commercial approval of the device.
The Portico NG valve has been modified from its original (first-generation) design to include an outer cuff to reduce blood flow back to the heart and improve long term performance of the valve. The Portico NG valve is used in combination with the FlexNav delivery system, which has a smaller insertion size (compared to the first generation Portico delivery system), so it can more easily manoeuvre through narrow blood vessels, improve the doctor’s ability to precisely position the Portico NG valve in your diseased heart valve, and be easier for the study doctor to use.
It is possible these design features may reduce some of the known risks associated with transcatheter aortic valve implantation (TAVI) procedures, specifically the risk of blood vessel injuries and bleeding or the need for additional treatment of the valve.
The Study will enrol approximately 140 subjects at up to twenty sites in Europe, Australia and the USA. This will comprise of up to a total of 120 analysis subjects; in addition, up to a total of 20 roll-in subjects may be enrolled based on experience of the implanting physicians. 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 six visits:
• Screening
• Baseline
• Implant
• Discharge
• 30-day follow-up
• 12-month follow-upREC name
HSC REC B
REC reference
19/NI/0161
Date of REC Opinion
12 Sep 2019
REC opinion
Favourable Opinion