Portico NG Approval Study
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|ClinicalTrials.gov Identifier: NCT04011722|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : May 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Severe Aortic Stenosis||Device: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System Device: Navitor Titan Valve (35mm) Valve and Large 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 399 (includes up to 20 roll-ins) 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 Navitor Transcatheter Aortic Heart Valve implantation will undergo Navitor 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.
This study will also include a product size extension, Navitor Titan™ valve, which includes up to 90 subjects (Titan cohort) who will undergo an implant attempt with the Navitor Titan valve. Subjects enrolled in the Titan cohort will undergo the same screening, baseline, procedure and follow-up assessments as the Portico NG cohort.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||399 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Devices under investigation in this clinical study include the Portico™ (Navitor) Valve (23mm, 25mm, 27mm and 29mm sizes), Navitor Titan Valve (35 mm), FlexNav™ Delivery System (small and large) and Portico™ NG (Navitor) Loading System(s) (small and large), and Navitor Loading System - LG+, 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|
|Actual Study Start Date :||September 17, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||October 2027|
Experimental: Portico™ NG (Navitor) valve, FlexNav™ Delivery System
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Device: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Experimental: Navitor Titan Valve
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Device: Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large 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 moderate or greater paravalvular leak [ Time Frame: at 30 days ]
- Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications [ 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 firstname.lastname@example.org|
|Contact: Mary-Margaret Seale||+1 612 513 email@example.com|