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Portico NG Approval Study

Primary Purpose

Symptomatic Severe Aortic Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Severe Aortic Stenosis focused on measuring Aortic Stenosis, Transcatheter Aortic Valve Implantation, Heart Valve Disease, High Surgical Risk, Portico NG (Navitor) Valve, Extreme Surgical Risk, Navitor Titan Valve

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Los Robles Regional Medical Center
  • Washington Hospital Center
  • Advocate Christ Medical Center
  • St. Vincent Hospital
  • Cardiovascular Research Institute of Kansas
  • Sparrow Clinical Research Institute
  • Minneapolis Heart Institute
  • Atlantic Health System - Morristown Memorial Hospital
  • Albany Medical Center
  • Columbia University Medical Center/NYPH
  • Montefiore Medical Center - Moses Division
  • Mission Health & Hospitals
  • University Hospitals Cleveland Medical Center
  • Providence St. Vincent Medical Center
  • University of Pittsburgh Medical Center
  • Baptist Memorial Hospital
  • Vanderbilt University Medical Center
  • The Methodist Hospital
  • The Heart Hospital Baylor Plano
  • Intermountain St. George Regional Hospital
  • Sentara Norfolk General Hospital
  • St. Andrew's Hospital
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • Rigshospitalet
  • Policlinico San Donato
  • Royal Victoria Hospital
  • Morriston Hospital - ABM University Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Portico™ NG (Navitor) valve, FlexNav™ Delivery System

Navitor Titan Valve

Arm Description

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 (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.

Outcomes

Primary Outcome Measures

Primary safety endpoint is all-cause mortality
Primary effectiveness endpoint is moderate or greater paravalvular leak

Secondary Outcome Measures

Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications

Full Information

First Posted
July 4, 2019
Last Updated
October 16, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04011722
Brief Title
Portico NG Approval Study
Official Title
Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Severe Aortic Stenosis
Keywords
Aortic Stenosis, Transcatheter Aortic Valve Implantation, Heart Valve Disease, High Surgical Risk, Portico NG (Navitor) Valve, Extreme Surgical Risk, Navitor Titan Valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portico™ NG (Navitor) valve, FlexNav™ Delivery System
Arm Type
Experimental
Arm Description
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).
Arm Title
Navitor Titan Valve
Arm Type
Experimental
Arm Description
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Intervention Type
Device
Intervention Name(s)
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Intervention Description
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 Outcome Measure Information:
Title
Primary safety endpoint is all-cause mortality
Time Frame
at 30 days
Title
Primary effectiveness endpoint is moderate or greater paravalvular leak
Time Frame
at 30 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Atlantic Health System - Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Montefiore Medical Center - Moses Division
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mission Health & Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain St. George Regional Hospital
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
St. Andrew's Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Policlinico San Donato
City
San Donato Milanese
State/Province
Lombard
ZIP/Postal Code
20097
Country
Italy
Facility Name
Royal Victoria Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Morriston Hospital - ABM University Health Board
City
Morriston
State/Province
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Portico NG Approval Study

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