Portico Next Generation Approval Study

Not Applicable

Active, not recruiting

Conditions: Symptomatic Severe Aortic Stenosis

Interventions: Device: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
Device: Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System

Registration Number: NCT04011722

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

Detailed Description: 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 333

Inclusion Criteria

Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)

Key

Exclusion Criteria

Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³). History of bleeding diathesis or coagulopathy
Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
Minimum access vessel diameter of <5.0mm for small FlexNav™ Delivery System and <5.5 mm for large FlexNav™ Delivery System

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Portico™ NG (Navitor) valve, FlexNav™ Delivery System	Portico™ NG (Navitor) Valve and 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).
Navitor Titan Valve	Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System	Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint is All-cause Mortality	at 30 days	All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak	at 30 days	Number of participants with moderate or greater paravalvular leak at 30 days.

Secondary Outcome Measures

Name	Time	Method
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications	at 30 days	The secondary endpoint is defined as a non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications at 30 days.

Trial Locations

Locations (28): Via Christi Regional Medical Center
🇺🇸
Wichita, Kansas, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Los Robles Regional Medical Center
🇺🇸
Thousand Oaks, California, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
Minneapolis Heart Institute
🇺🇸
Minneapolis, Minnesota, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
Mission Health & Hospitals
🇺🇸
Asheville, North Carolina, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Columbia University Medical Center/NYPH
🇺🇸
New York, New York, United States
Montefiore Medical Center - Moses Division
🇺🇸
New York, New York, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Intermountain St. George Regional Hospital
🇺🇸
Saint George, Utah, United States
St. Andrew's Hospital
🇦🇺
Adelaide, South Australia, Australia
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺
Murdoch, Western Australia, Australia
Rigshospitalet
🇩🇰
Copenhagen, Denmark
Policlinico San Donato
🇮🇹
San Donato Milanese, Lombard, Italy
Royal Victoria Hospital
🇬🇧
Belfast, Northern Ireland, United Kingdom
Morriston Hospital - ABM University Health Board
🇬🇧
Morriston, Swansea, United Kingdom