Portico NG Approval Study

Symptomatic Severe Aortic Stenosis Clinical Trial

Official title:

Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04011722
• Other study ID #: ABT-CIP-10297
• Secondary ID: ABT-CIP-10308
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 333
• Est. completion date: December 2027
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Key Inclusion Criteria:

1. 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.

2. Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.

3. 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).

4. 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:

1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.

2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.

3. 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

4. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation

5. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).

6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).

7. 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.

8. Minimum access vessel diameter of <5.0mm for small FlexNav™ Delivery System and <5.5 mm for large FlexNav™ Delivery System

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Symptomatic Severe Aortic Stenosis

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint is all-cause mortality		at 30 days
Primary	Primary effectiveness endpoint is moderate or greater paravalvular leak		at 30 days
Secondary	Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications		at 30 days