Portico NG Approval Study
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|ClinicalTrials.gov Identifier: NCT04011722|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Severe Aortic Stenosis||Device: Portico™ NG Valve and FlexNav™ Delivery System||Not Applicable|
The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study.
Up to 140 high or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico NG Transcatheter Aortic Heart Valve implantation will undergo Portico™ NG Valve implantation via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure.
Subjects participating in the clinical study will be followed for a total of 12 months with data collected at screening, baseline, procedure, prior to hospital discharge, and follow-up at 30 days, 12 months and annually at 2, 3, 4 and 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Devices under investigation in this clinical study include the Portico™ NG Valve (23mm, 25mm, 27mm and 29mm sizes), FlexNav™ Delivery System(s) (small and large) and Portico™ NG Loading System(s) (small and large), all of which are currently approved for investigational use only.|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis|
|Estimated Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||February 2026|
Experimental: Portico™ NG valve, FlexNav™ Delivery System
Portico valve implantation with the new generation Portico NG valve (23mm, 25mm, 27mm and 29mm sizes), second-generation FlexNav Delivery system (small and large) and Portico™ NG Loading System(s) (small and large)
Device: Portico™ NG Valve and FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the new generation Portico NG valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
- Primary safety endpoint is all-cause mortality [ Time Frame: at 30 days ]
- Primary effectiveness endpoint is freedom from moderate or greater paravalvular leak [ Time Frame: at 30 days ]
- Secondary endpoint is freedom from mild or greater paravalvular leak [ Time Frame: at 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011722
|Contact: Mira Tissari||+32 470 47 email@example.com|
|Contact: Mary-Margaret Seale||+1 612 513 firstname.lastname@example.org|