Portico Next Generation Approval Study
Evaluation of the Portico™ NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
2 other identifiers
interventional
333
5 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2023
CompletedResults Posted
Study results publicly available
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJuly 31, 2025
July 1, 2025
3.3 years
July 4, 2019
April 29, 2024
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Safety Endpoint is All-cause Mortality
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
at 30 days
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Number of participants with moderate or greater paravalvular leak at 30 days.
at 30 days
Secondary Outcomes (1)
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
at 30 days
Study Arms (2)
Portico™ NG (Navitor) valve, FlexNav™ Delivery System
EXPERIMENTALPortico ™ 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
EXPERIMENTALNavitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
St. Vincent Hospital
Indianapolis, Indiana, 46240, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Albany Medical Center
Albany, New York, 12208, United States
Columbia University Medical Center/NYPH
New York, New York, 10032, United States
Montefiore Medical Center - Moses Division
New York, New York, 10467, United States
Mission Health & Hospitals
Asheville, North Carolina, 28801, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
The Methodist Hospital
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Intermountain St. George Regional Hospital
St. George, Utah, 84790, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
St. Andrew's Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Rigshospitalet
Copenhagen, 2100, Denmark
Policlinico San Donato
San Donato Milanese, Lombard, 20097, Italy
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA, United Kingdom
Morriston Hospital - ABM University Health Board
Morriston, Swansea, SA6 6NL, United Kingdom
Related Publications (1)
Reardon MJ, Chehab B, Smith D, Walton AS, Worthley SG, Manoharan G, Sultan I, Yong G, Harrington K, Mahoney P, Kleiman N, Makkar RR, Fontana G, DeLago A, Ramana RK, Bates N, Sondergaard L. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. JACC Cardiovasc Interv. 2023 Mar 27;16(6):681-689. doi: 10.1016/j.jcin.2023.02.002. Epub 2023 Feb 27.
PMID: 36990558DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nels Engblom
- Organization
- Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
July 8, 2019
Study Start
September 17, 2019
Primary Completion
January 12, 2023
Study Completion (Estimated)
December 1, 2027
Last Updated
July 31, 2025
Results First Posted
July 1, 2024
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share